System and method for remote programming of an implantable medical device

ABSTRACT

A method and corresponding system for updating or installing new software loaded into the memory of an implantable medical device(IMD) implanted within a body of a patient is described. The updated or new software may be installed in the memory of the IMD without the patient having to travel to a clinic or hospital, and may be effected by employing modem telecommunication and Internet techniques in conjunction with a remote computer system.

[0001] The present invention relates generally to medical devicesystems, and more particularly relates to a system and method forcommunication between an IMD and a remote computer and/or health careprovider employing a mobile telephone and a communication module linkedthereto.

BACKGROUND OF THE INVENTION

[0002] An ideal technology-based health care system would be capable offully integrating the technical and social aspects of patient care andtherapy and permit a patient or a medical device implanted within thepatient to communicate a remote computer system or health care providerirrespective of the location of the patient, the remote computer systemor the health care provider. While clinicians will continue to treatpatients in accordance with accepted modem medical practice,developments in communications technology are making it ever morepossible to provide medical services in a time and place independentmanner.

[0003] Prior art methods of providing clinical medical services aregenerally limited to in-hospital or in-clinic procedures. For example,if a physician must review the performance parameters of an implantablemedical device (hereinafter “IMD”) in a patient, it is likely thepatient will have to visit a clinic or hospital where the review canaccomplished. If the medical conditions of a patient having an IMDwarrant continuous monitoring or adjustment of the device, the patientmay have to remain at the hospital. Such continued treatment poseseconomic and social problems. Additionally, patients' physical movementsare restricted and patients are inconvenienced by the need to visit orstay in a hospital or a clinic. As the proportion of the population withimplanted medical devices increases, ever more hospitals, clinics andservice personnel will be required to provide in-hospital or in-clinicservices to such patients, thus escalating healthcare costs.

[0004] In accordance with prior art practice, most patient having IMDsare required to visit a clinical center for occasional retrieval of datatherefrom. Typically, the IMD's performance is assessed and patient dataare acquired for clinical and research purposes. Such data is usuallyacquired by having the patient visit a hospital or clinic where datastored in the memory of the IMD is uploaded to a programmer. Dependingon the frequency of data acquisition and storage, this procedure canresult in difficulty and inconvenience for patients living in ruralareas or having limited physical mobility. Similarly, if the software inan IMD must be updated, the patient is required to come into a clinic orhospital to have the upgrade installed.

[0005] The prior art discloses various types of remote sensing andcommunication systems that interact with IMDs. One such system isdisclosed in Funke, U.S. Pat. No. 4,987,897. This patent discloses asystem that is at least partially implanted into a living body with aminimum of two implanted devices interconnected by a communicationtransmission channel. The invention further discloses wirelesscommunications between an external medical device/programmer and animplanted device.

[0006] Another example of a prior art sensing and communication systemis disclosed by Strandberg in U.S. Pat. No. 4,886,064. In this patent,body activity sensors, such as temperature, motion, respiration and/orblood oxygen sensors, are positioned in a patient's body outside a pacercapsule. The sensors wirelessly transmit body activity signals, whichare processed by circuitry in the heart pacer. The heart pacingfunctions are influenced by the processed signals. The signaltransmission is a two-way network and allows the sensors to receivecontrol signals for altering the sensor characteristics.

[0007] In U.S. Pat. No. 4,494,950, Fischell discloses a systemconsisting of a plurality of separate modules that collectively performa useful biomedical purpose. The modules communicate electromagneticallywith one another without the use of interconnecting wires. Physiologicsensor measurements sent from a first module cause a second module toperform some function in a closed loop manner.

[0008] One example of remote monitoring of implanted cardioverterdefibrillators is U.S. Pat. No. 5,321,618 to Gessman, where a remoteapparatus is adapted to receive commands from and transmit data to acentral monitoring facility over telephone communication channels. Theremote apparatus includes equipment for acquiring a patient's ECG andtransmitting same to the central facility using telephone communicationschannels. The remote apparatus also includes a segment, responsive to acommand received from the central monitoring facility, for enabling theemission of audio tone signals from the cardioverter defibrillator. Theaudio tones are detected and sent to the central monitoring facility viathe telephone communication channel. The remote apparatus also includespatient alert devices, which are activated by commands received from thecentral monitoring facility over the telephone communication channel.

[0009] An additional example of prior art practice includes apacket-based telemedicine system for communicating information betweencentral monitoring stations and a remote patient monitoring stationdisclosed by Pfeiffer in WO 99/14882 published Mar. 25, 1999. Thisdisclosure relates to a packet-based telemedicine system forcommunicating video, voice and medical data between a central monitoringstation and a patient that is remotely located with respect to thecentral monitoring station. The patient monitoring station obtainsdigital video, voice and medical measurement data from a patient andencapsulates the data in packets and sends the packets over a network tothe central monitoring station. Since the information is encapsulated inpackets, the information can be sent over multiple types or combinationof network architectures, including a community access television (CATV)network, the public switched telephone network (PSTN), the integratedservices digital network (ISDN), the Internet, a local area network(LAN), a wide area network (WAN), over a wireless communicationsnetwork, or over asynchronous transfer mode (ATM) network. A separatetransmission code is not required for each different type oftransmission media.

[0010] Another example of a telemetry system for IMDs is disclosed byDuffin et al. in U.S. Pat. No. 5,752,976. The Duffin disclosure relatesto a system and method for communicating with a medical device implantedin an ambulatory patient and for locating the patient in order toselectively monitor device function from a remote medical supportnetwork. The communications link between the medical support network andthe patient communications control device may comprise a world widesatellite network, a cellular telephone network or other personalcommunications system.

[0011] Thompson et al. disclose a patient tracking system in U.S. PatentNos. 6,083,248 and 5,752,976 entitled “World-wide Patient Location andData Telemetry System For IMDs”. Thompson et al. also describe featuresfor patient tracking in a mobile environment worldwide via the GPSsystem.

[0012] Ferek-Petric discloses a system for communication with a medicaldevice in co-pending U.S. patent application Ser. No. 09/348,506entitled “System for Remote Communication with a Medical Device” filedJul. 7, 1999. Ferek-Petric's disclosure relates to a system that permitsremote communications with a medical device, such as a programmer.Experts provide guidance and support to remote service personnel oroperators located at the programmer. The system may include a medicaldevice adapted to be implanted into a patient; a server PC communicatingwith the medical device; the server PC having means for receiving datatransmitted across a dispersed data communication pathway, such as theInternet; and a client PC having means for receiving data transmittedacross a dispersed communications pathway from the SPC. In certainconfigurations the server PC may have means for transmitting data acrossa dispersed data communication pathway (Internet) along a first channeland a second channel; and the client PC may have means for receivingdata across a dispersed communication pathway from the server PC along afirst channel and a second channel.

[0013] Ferek-Petric further discloses the implementation ofcommunication systems associated with IMDs that are compatible with theInternet. The communications scheme is structured primarily to alertremote experts to existing or impending problems with the programmingdevice so that prudent action, such as early maintenance or otherremedial steps, may be exercised in a timely manner. Further, because ofthe early warning or advance knowledge of the problem, the remote expertwould be well informed to provide remote advice or guidance to servicepersonnel or operators at the programmer.

[0014] In U.S. Pat. No. 5,800,473, Faisandier et al. provide a systemand method for the automatic update of the software of an externalprogrammer implant that is used to program and configure an active IMDimplant and acquire data obtained by the implant. The programmercomprises software composed of an assembly of software objects. Theimplant comprises a memory containing parametric data for thefunctioning of the implant and an assembly of software objects necessaryfor the functioning of the programmer in connection with the parametricdata.

[0015] In U.S. Pat. No. 5,772,586 to Heinonen et al., there is discloseda method for monitoring the health of a patient by utilizingmeasurements. The measurements are supplied via a communication deviceutilizing a wireless data transmission link to a data processing systemavailable to the person monitoring the patient's health. The patient'shealth is monitored by means of the data stored in the data processingsystem.

[0016] In EP 0 987 047 A2 to Lang et al. entitled “Patient MonitoringSystem” having a priority date of Sep. 18, 1998, there is a descriptionof sensing and acquiring physiological data with a pacemaker ordefibrillator, and transmitting those data by mobile phone to anexternal system accessible by a cardiologist. The cardiologist may thenevaluate the data and initiate emergency action such ordering anambulance. The mobile phone may also be employed to determine thepatient's geographical location, as well as to transmit a signal warningof a low state of charge in the pacemaker or defibrillator battery.

[0017] It will now be seen that there exist many unfulfilled needs tomore easily, quickly and cost-effectively monitor and control theperformance of an IMD in a patient on a regular or continuous basis,where the patient is not required to visit a health care facility or ahealth care provider in person when the monitoring is undertaken. Itwill also now be seen that there exist many unfulfilled needs to moreeasily, quickly and cost effectively monitor and control the health of apatient having an IMD on a regular or continuous basis, where thepatient is not required to visit a health care facility or a health careprovider in person when the monitoring is undertaken. Ambulatorypatients suffering from atrial fibrillation, chronic pain, bradycardia,syncope, tachycardia and other maladies treated with IMDs need a tool tocommunicate with their physicians or other health care providers whenthey want to. There are now over 2.5 million ambulatory implantablepacemaker patients, virtually all of whom must visit a clinic orhospital to have their health status or pacemaker performance checked.

[0018] Patents and printed publications describing various aspects ofthe foregoing problems and the state of the art are listed below. TABLE1 PATENTS U.S. or Foreign Patent or Patent Issue Date Application/ orPublication No. Inventor(s) Foreign Priority Date U.S. 4,494,950Fischell Jan. 22, 1985 U.S. 4,531,523 Anderson Jul. 30, 1985 U.S.531,527 Reinhold, JR. et al. Jul. 30, 1985 U.S. 4,768,176 Kehr et al.Aug. 30, 1988 U.S. 4,768,177 Kehr et al. Aug. 30, 1988 U.S. 4,886,064Strandberg Dec. 12, 1989 U.S. 4,987,897 Funke Jan. 29, 1991 U.S.5,047,948 Turner Sept. 10, 1991 U.S. 5,100,380 Epstein et al. Mar. 31,1992 U.S. 5,113,869 Nappholz et al. May 19, 1992 U.S. 5,172,698 StankoDec. 22, 1992 U.S. 5,200,891 Kehr et al. Apr. 6, 1993 U.S. 5,226,425Righter Jul. 13, 1993 U.S. 5,321,618 Gessman Jun. 14, 1994 U.S.5,336,245 Adams Theodore P et al. Aug. 9, 1994 U.S. 5,338,157 BlomquistAug. 16, 1994 U.S. 5,354,319 Blomquist Oct. 11, 1994 U.S. 5,369,699 Pageet al. Nov. 29, 1994 U.S. 5,400,246 Wilson et al. Mar. 21, 1995 U.S.5,522,396 Langer et al. Jun. 4, 1996 U.S. 5,526,630 Markowitz et al. May6, 1997 U.S. 5,573,506 Vasko Nov. 12, 1996 U.S. 5,582,593 Hultman Dec.10, 1996 U.S. 5,619,991 Sloane Apr. 15, 1997 U.S. 5,634,468 Platt et al.Jun. 3, 1997 U.S. 5,642,731 Kehr Jul. 1, 1997 U.S. 5,643,212 Coutre etal. Jul. 1, 1997 U.S. 5,678,562 Sellers Oct. 21, 1997 U.S. 5,683,432Goedeke et al. Nov. 4, 1997 U.S. 5,697,959 Poore Dec. 16, 1997 U.S.5,719,761 Gatti et al. Feb. 17, 1998 U.S. 5,720,770 Nappholz et al. Feb.24, 1998 U.S. 5,720,771 Snell Feb. 24, 1998 U.S. 5,722,999 Snell Mar. 3,1998 U.S. 5,749,907 Mann May 12, 1998 U.S. 5,752,235 Demenus et al. May12, 1998 U.S. 5,752,976 Duffin et al. May 19, 1998 U.S. 5,791,342Woodard Aug. 11, 1998 U.S. 5,800,473 Faisandier Sep. 1, 1998 U.S.5,839,438 Craettinger et al. Nov. 24, 1998 U.S. 5,843,138 Goedeke et al.Dec. 1, 1998 U.S. 5,848,593 Mcgrady et al. Dec. 15, 1998 U.S. 5,855,609Knapp Jan. 5, 1999 U.S. 5,857,967 Frid et al. Jan. 12, 1999 U.S.5,876,351 Rohde Mar. 2, 1999 U.S. 5,895,371 Levital et al. Apr. 20, 1999U.S. 5,912,818 McGrady et al. Jun. 15, 1999 U.S. 5,941,906 Barreras Sr.et al. Aug. 24, 1999 U.S. 5,944,659 Flach et al. Aug. 31, 1999 U.S.5,954,641 Kehr et al. Sep. 21, 1999 U.S. 5,971,593 McGrady Oct. 26, 1999U.S. 5,974,124 Schlueter, Jr. et al. Oct. 26, 1999 U.S. 5,977,431 Knappet al. Nov. 2, 1999 U.S. 5,987,519 Peifer et al. Nov. 16, 1999 U.S.5,993,046 McGrady et al. Nov. 30, 1999 U.S. 6,004,020 Bartur Dec. 21,1999 U.S. 6,006,035 Nabahi Dec. 21, 1999 U.S. 6,022,315 Iliff Feb. 8,2000 U.S. 6,023,345 Bloomfield Feb. 8, 2000 U.S. 6,024,539 BlomquistFeb. 15, 2000 U.S. 6,025,931 Bloomfield Feb. 15, 2000 U.S. 6,035,328Soukal Mar. 7, 2000 U.S. 6,053,887 Levitas et al. Apr. 25, 2000 WO99/14882 Pfeifer et al. Mar. 25, 1999 WO 97/00708 Duffin et al. Jan. 9,1997 EP 0 987 047 A2 Lang et al. Sept. 18, 1998 EP 062 976 A2 Schaldachet al. June 26, 1999 EP 062 980 A2 Kraus et al. June 25, 1999 EP 062 981A2 Kraus et al. June 25, 1999 EP 062 982 A2 Kraus et al. June 25, 1999EP 062 983 A2 Kraus et al. June 25, 1999 EP 062 984 A2 Kraus et al. June25, 1999 EP 062 985 A2 Kraus et al. June 25, 1999 EP 062 986 A2Lorkowski et al. June 25, 1999

[0019] All patents and printed publications listed hereinabove arehereby incorporated by reference herein, each in its respectiveentirety. As those of ordinary skill in the art will appreciate readilyupon reviewing the drawings set forth herein and upon reading theSummary of the Invention, Detailed Description of the PreferredEmbodiments and claims set forth below, at least some of the devices andmethods disclosed in the patents and publications listed hereinabove maybe modified advantageously in accordance with the teachings of thepresent invention.

SUMMARY OF THE INVENTION

[0020] Various embodiments of the present invention have certainobjects. That is, various embodiments of the present invention providesolutions to problems existing in the prior art, including, but notlimited to, problems such as: (a) requiring patients having IMDs tovisit a hospital or clinic for routine monitoring of the patient'shealth; (b) requiring patients having IMDs to visit a hospital or clinicfor routine monitoring of the IMD's performance; (c) requiring patientshaving IMDs to visit a hospital or clinic when the IMD is to bere-programmed; (d) relatively long periods of time passing (e.g., hours,days or even weeks) between the time a patient first detects a problemwith the operation of an IMD or the patient's health on the one hand,and the time the problem is actually diagnosed and/or acted upon by aphysician or other health care professional on the other hand; (e) IMDperformance monitoring being relatively expensive owing to patientsbeing required to visit a clinic or hospital; (f) monitoring of patientshaving IMDs being relatively expensive owing to patients being requiredto visit a clinic or hospital; (g) existing remote patient monitoringtelephony systems being expensive, bulky, unwieldy, stationary, andlimited in application; (h) existing remote IMD monitoring telephonysystems being expensive, bulky, unwieldy, stationary, and limited inapplication; (i) complicated, expensive, non-uniform and time-consumingbilling, invoicing and reimbursement systems for medical servicesrendered.

[0021] Various embodiments of the present invention have certainadvantages, including, without limitation, one or more of: (a) reducing,if not eliminating, the requirement for a patient having an IMD to visita clinic or a hospital for routine check-ups or monitoring of the IMD;(b) substantially reducing costs associated with monitoring patientshaving IMDs; (c) substantially reducing costs associated with monitoringthe performance of IMDs; (d) providing a patient having an IMD with theability to contact a health care provider or health care providerservice almost instantly in respect of the patient's current healthstatus; (e) providing a patient with the ability to contact a healthcare provider or health care provider service almost instantly inrespect of the performance of the IMD; (f) providing a patient having anIMD with the ability to contact a health care provider or health careprovider service in respect of the patient's current health status fromalmost any location; (g) providing a patient having an IMD with theability to contact a health care provider or health care providerservice in respect of the performance of the IMD from almost anylocation; (h) providing a health care provider or service provider withthe ability to contact almost instantly a patient having an IMD inrespect of the patient's current health status; (I) providing a healthcare provider or service provider with the ability to contact almostinstantly a patient having an IMD in respect of the performance of theIMD; (j) providing a health care provider or service provider with theability to contact a patient located almost anywhere having an IMD inrespect of the patient's current health status; (k) providing a healthcare provider or service provider with the ability to contact a patientlocated almost anywhere having an IMD in respect of the performance ofthe IMD; (l) providing a health care provider or service provider withthe ability to re-program an IMD located almost anywhere; (m) providinga health care provider or service provider with the ability to quicklydownload new software to an IMD located almost anywhere; (n) providing ahealth care provider or service provider, or a patient having an IMD, tocontact an emergency medical service quickly in the event monitoring ofthe patient or the IMD reveals such a service is required; (o) providinga computer system with the ability to automatically and quickly contactan emergency medical service in the event monitoring of the patient orthe IMD reveals such a service is required; (p) enabling remote softwaredebugging, analysis, troubleshooting, maintenance and upgrade of the IMDor the communication module, and (q) generating medical service invoicesautomatically and efficiently.

[0022] Various embodiments of the present invention have certainfeatures, including one or more of the following: (a) a communicationmodule, separate from, connectable to, or integral with a mobiletelephone, the module being capable of communicating with an IMD and themobile telephone; (b) a communication module capable of communicatingwith an IMD and a mobile telephone comprising a microprocessor, acontroller or other CPU, computer readable memory operable connected tothe microprocessor, controller or CPU, and at least one RF or othersuitable type of communications circuit for transmitting information toand receiving information from the IMD; (c) a communication modulecapable of communicating with an IMD and a mobile telephone comprising adata output port, cable and connector for connection to a mobiletelephone data input port; (d) a communication module capable ofcommunicating with an IMD and a mobile telephone comprising computerreadable software for initiating and maintaining communications with amobile telephone using standardized handshake protocols; (e) acommunication module capable of communicating with an IMD and a mobiletelephone comprising at least one of: a telemetry signal strengthindicator, a telemetry session success indicator; a computer readablemedium (such as volatile or nonvolatile RAM, ROM, EEPROM, a hard orfloppy disk, flash memory, and so on) for storing patient data and/orIMD data and/or software; a real-time clock; a battery; a serial outputinterface; a parallel output interface; (f) a communication modulecapable of communicating with an IMD and a mobile telephone, the modulebeing electrically powered by a portable energy source such as a batterylocated in, or connected or attached to the mobile phone, oralternatively being electrically powered by its own portable energysource or household line ac power; (g) a communication module capable ofcommunicating with an IMD and a mobile telephone, the module beingplug-and-play compatible with the mobile telephone; (h) a communicationmodule capable of communicating with an IMD and a mobile telephone, themodule, upon receiving instruction from a patient having the medicaldevice implanted therein, interrogating the implantable device to assessoperational performance of the device and/or the health status of thepatient, the module storing in a computer readable medium and/orrelaying such information to the patient or to a remote computer via themobile telephone; (I) a communication module capable of communicatingwith an IMD and a mobile telephone, the module, upon receivinginstruction from a remote computer via the mobile telephone,interrogating the implantable device to assess operational performanceof the device and/or the health status of the patient, the modulerelaying such information to the patient or to a remote computer via themobile telephone; (j) a communication module capable of communicatingwith an IMD and a mobile telephone, the module, upon receivinginstruction from a remote computer via the mobile telephone, relayinginformation stored in a computer readable storage medium containedwithin or attached to the module, where the information concernsperformance of the IMD or the module, and/or the health status of thepatient, to the patient and/or the remote computer via the mobiletelephone; (k) use of a robust web-based remote expert data center,remote computer system or remote health care provider or health careprovider, preferably accessible worldwide, to manage and tune softwarerelating to the operational and functional parameters of thecommunication module or the IMD, most preferably in real-time or nearreal-time; (l) remote diagnosis, analysis, maintenance, upgrade,performance tracking, tuning and adjustment of a communication module orIMD from a remote location; (m) use of a highly flexible and adaptablecommunications scheme to promote continuous and preferably real-timedata communications between a remote expert data center, remotecomputer, and/or remote health care provider or health care provider andthe communication module via a mobile telephone; (n) a communicationssystem capable of detecting whether a component or software defectexists in the IMD and/or the communication module; (o) a communicationssystem wherein if a defect or fault is discovered, the system is capableof determining whether a remote “fix” is possible—if not, the systembroadcasts an alert to a remote health care provider, remote computer orremote expert based computer system, most preferably attending to theproblem on a real-time basis; (p) a communications system capable ofperforming, by way of example only, data base integrity checks, meantime between failure status of predetermined components and theirassociated embedded systems; (q) a communications system capable ofmining patient history, performance parameter integrity and softwarestatus from the communication module, (r) an automatic medical serviceinvoicing or billing system, and (s) methods and processes associatedwith all the foregoing devices and/or systems.

[0023] One embodiment of the present invention relates generally to acommunications scheme in which a remote computer or computer system, ora remote health care provider, communicates with an IMD implanted withina patient by communicating through a mobile telephone and/or PDA and acommunication module located near the patient, where the communicationmodule is operatively connected to the mobile telephone and/or PDA andis capable of telemetrically uploading and downloading information toand from the IMD, and thence via the mobile telephone or PDA to theremote computer or health care provider. In some embodiments of thepresent invention, communications between the remote computer system orremote health care provider and the IMD include remotely debugging,updating or installing new software in the IMD or the communicationmodule.

[0024] Another embodiment of the present invention comprises acommunication module linked or connected via a mobile telephone to aremote health care provider or remote computer through the now nearlyglobal mobile telephone communications network (which here is defined toinclude the Internet). At one end of the operative structure there is aremote computer, a remote web-based expert data center, and/or a remotehealth care provider. At the other end of the operative structure lies amobile telephone or PDA operatively connected to a communication module,where the communication module is in turn capable of communicating withthe IMD and is optionally capable of storing information obtained fromthe IMD therein. In-between the two foregoing ends of the system of thatembodiment lies the worldwide telephone/Internet communications system.

[0025] In yet another embodiment of the present invention, the criticalcomponents, embedded systems of and software in the communication moduleand/or the IMD may be remotely maintained, debugged and/or evaluated viathe mobile telephone and/or PDA to ensure proper functionality andperformance by down-linking suitable software or diagnostic routines orinstructions originating at the remote computer, the remote health careprovider, or the remote web-based expert data center, or by up-linkingsoftware loaded into the communication module and/or IMD for comparisonor evaluation by the remote computer, the remote health care provider,or the remote web-based expert data center. The operational andfunctional software of the embedded systems in the IMD and/or thecommunication module may be remotely adjusted, upgraded or changed asrequired. At least some software changes may be implemented in the IMDby downlinking from the communication module to the IMD.

[0026] In some embodiments of the present invention, the performance ofthe IMD, or physiologic signals or data indicative of the patient'shealth status, may be remotely monitored or assessed by the remotehealth care provider, the remote computer or computer system, or theremote expert data center via the mobile telephone and/or PDA and thecommunication module.

[0027] In other embodiments of the present invention, there are providedcommunications systems comprising integrated and efficient methods andstructures for clinical information management in which variousnetworks, such as by way of example only, Local Area Networks (LANs),Wide Area Network (WANs), Integrated Services Digital Network (ISDNs),Public Switched telephone Networks (PSTNs), the Internet, wirelessnetworks, asynchronous transfer mode (ATM) networks, satellites, mobiletelephones and other networks are implemented and coordinated with oneanother to transfer information to and from the IMD through thecommunication module and the mobile telephone to a remote computer,remote computer system, remote expert network, and/or a remote healthcare provider or other authorized user.

[0028] In the interest of brevity and simplicity, the applicants referto the various foregoing and other communications system as“communications systems.” It is to be noted, however, that suchcommunication systems are interchangeable in the context of the presentinvention and may relate to various types of cable, fiber optic,microwave, radio, laser and other communication systems, or anypractical combinations thereof.

[0029] The present invention provides significant compatibility andscalability in respect of web-based applications such as telemedicineand emerging web-based technologies such as tele-immersion. For example,the system may be adapted to applications in which a mobile telephoneuplinks to a remote data center, remote computer, remote computer systemor remote health care provider or authorized user via a mobile telephoneto transfer data stored in the communication module or obtained from theIMD, or to receive data from such remote computers or health careproviders. In these and other applications, the data so transferred orreceived may be employed as a preliminary screening tool to identify theneed for further intervention or action using web technology.

BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The present invention will become better understood by referenceto the following Detailed Description of the Preferred Embodiments ofthe present invention when considered in connection with theaccompanying Figures, in which like numbers designate like partsthroughout, and where:

[0031]FIG. 1 shows a simplified schematic view of one embodiment of anIMD that may be employed in conjunction with the present invention;

[0032]FIG. 2 shows a simplified illustration of an IMD with medicalelectrical leads positioned within passageways of a heart;

[0033]FIG. 3 shows a block diagram illustrating some constituentcomponents of an IMD;

[0034]FIG. 4 shows a simplified schematic view of an IMD with medicalelectrical leads positioned within passageways of a heart;

[0035]FIG. 5 shows a partial block diagram illustrating one embodimentof an IMD that may be employed in conjunction with the presentinvention;

[0036]FIGS. 6A through 6C show simplified schematic and flow diagrams ofvarious embodiments of the principal communications components of thepresent invention;

[0037]FIG. 7 shows a block diagram illustrating major components of oneembodiment of a communication module of the present invention;

[0038]FIG. 8 illustrates various portions of a communications system inaccordance with one embodiment of the present invention;

[0039]FIGS. 9A and 9B show flow charts for two methods of the presentinvention relating to patient-initiated communication between IMD 10and/or communication module 100/mobile telephone or PDA 110 and variouscomponents of remote system 130 via communication system 120;

[0040]FIG. 9C shows another method of the present invention related tothe methods illustrated in FIGS. 9A and 9B;

[0041]FIGS. 10A and 10B show flow charts for two methods of the presentinvention relating to device-initiated communication between IMD 10and/or communication module 100/mobile telephone or PDA 110 and variouscomponents of remote system 130 via communication system 120;

[0042]FIGS. 11A and 11B show flow charts for two methods of the presentinvention relating to remote system 130 and/or remote health careprovider 136 initiated communication between IMD 10 and/or communicationmodule 100 and/or mobile telephone or PDA 110 and various components ofremote system 130 via communication system 120;

[0043]FIG. 12A shows one embodiment of communication module 100, mobiletelephone or PDA 110, communication system 120, and remote computersystem 130 of the present invention;

[0044]FIGS. 12B and 12C show two methods of the present inventionassociated with updating, debugging, downloading and/or uploadingsoftware to or from IMD 10 in accordance with the systems and devices ofthe present invention, and

[0045]FIGS. 13A and 13B show flow charts for two methods of the presentinvention relating to emergency-initiated communication between IMD 10and/or communication module 100/mobile telephone or PDA 110 and variouscomponents of remote system 130 via communication system 120.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0046]FIG. 1 is a simplified schematic view of one embodiment ofimplantable medical device (“IMD”) 10 of the present invention. IMD 10shown in FIG. 1 is a pacemaker comprising at least one of pacing andsensing leads 16 and 18 attached to hermetically sealed enclosure 14 andimplanted near human or mammalian heart 8. Pacing and sensing leads 16and 18 sense electrical signals attendant to the depolarization andre-polarization of the heart 8, and further provide pacing pulses forcausing depolarization of cardiac tissue in the vicinity of the distalends thereof. Leads 16 and 18 may have unipolar or bipolar electrodesdisposed thereon, as is well known in the art. Examples of IMD 10include implantable cardiac pacemakers disclosed in U.S. Pat. No.5,158,078 to Bennett et al., U.S. Pat. No. 5,312,453 to Shelton et al.or U.S. Pat. No. 5,144,949 to Olson, all hereby incorporated byreference herein, each in its respective entirety.

[0047]FIG. 2 shows connector module 12 and hermetically sealed enclosure14 of IMD 10 located in and near human or mammalian heart 8. Atrial andventricular pacing leads 16 and 18 extend from connector header module12 to the right atrium and ventricle, respectively, of heart 8. Atrialelectrodes 20 and 21 disposed at the distal end of atrial pacing lead 16are located in the right atrium. Ventricular electrodes 28 and 29 at thedistal end of ventricular pacing lead 18 are located in the rightventricle.

[0048]FIG. 3 shows a block diagram illustrating the constituentcomponents of IMD 10 in accordance with one embodiment of the presentinvention, where IMD 10 is pacemaker having a microprocessor-basedarchitecture. IMD 10 is shown as including activity sensor oraccelerometer 11, which is preferably a piezoceramic accelerometerbonded to a hybrid circuit located inside enclosure 14. Activity sensor11 typically (although not necessarily) provides a sensor output thatvaries as a function of a measured parameter relating to a patient'smetabolic requirements. For the sake of convenience, IMD 10 in FIG. 3 isshown with lead 18 only connected thereto; similar circuitry andconnections not explicitly shown in FIG. 3 apply to lead 16.

[0049] IMD 10 in FIG. 3 is most preferably programmable by means of bothan external programming unit (not shown in the Figures) andcommunication module 100, more about which we say later. One suchprogrammer is the commercially available Medtronic Model 9790programmer, which is microprocessor-based and provides a series ofencoded signals to IMD 10, typically through a programming head whichtransmits or telemeters radio-frequency (RF) encoded signals to IMD 10.Such a telemetry system is described in U.S. Pat. No. 5,312,453 toWyborny et al., hereby incorporated by reference herein in its entirety.The programming methodology disclosed in Wyborny et al.'s '453 patent isidentified herein for illustrative purposes only. Any of a number ofsuitable programming and telemetry methodologies known in the art may beemployed so long as the desired information is transmitted to and fromthe pacemaker.

[0050] As shown in FIG. 3, lead 18 is coupled to node 50 in IMD 10through input capacitor 52. Activity sensor or accelerometer 11 is mostpreferably attached to a hybrid circuit located inside hermeticallysealed enclosure 14 of IMD 10. The output signal provided by activitysensor 11 is coupled to input/output circuit 54. Input/output circuit 54contains analog circuits for interfacing to heart 8, activity sensor 11,antenna 56 and circuits for the application of stimulating pulses toheart 8. The rate of heart 8 is controlled by software-implementedalgorithms stored microcomputer circuit 58.

[0051] Microcomputer circuit 58 preferably comprises on-board circuit 60and off-board circuit 62. Circuit 58 may correspond to a microcomputercircuit disclosed in U.S. Pat. No. 5,312,453 to Shelton et al., herebyincorporated by reference herein in its entirety. On-board circuit 60preferably includes microprocessor 64, system clock circuit 66 andon-board RAM 68 and ROM 70. Off-board circuit 62 preferably comprises aRAM/ROM unit. On-board circuit 60 and off-board circuit 62 are eachcoupled by data communication bus 72 to digital controller/timer circuit74. Microcomputer circuit 58 may comprise a custom integrated circuitdevice augmented by standard RAM/ROM components.

[0052] Electrical components shown in FIG. 3 are powered by anappropriate implantable battery power source 76 in accordance withcommon practice in the art. For the sake of clarity, the coupling ofbattery power to the various components of IMD 10 is not shown in theFigures. Antenna 56 is connected to input/output circuit 54 to permituplink/downlink telemetry through RF transmitter and receiver telemetryunit 78. By way of example, telemetry unit 78 may correspond to thatdisclosed in U.S. Pat. No. 4,566,063 issued to Thompson et al., herebyincorporated by reference herein in its entirety, or to that disclosedin the above-referenced '453 patent to Wyborny et al. It is generallypreferred that the particular programming and telemetry scheme selectedpermit the entry and storage of cardiac rate-response parameters. Thespecific embodiments of antenna 56, input/output circuit 54 andtelemetry unit 78 presented herein are shown for illustrative purposesonly, and are not intended to limit the scope of the present invention.

[0053] Continuing to refer to FIG. 3, V_(REF) and Bias circuit 82 mostpreferably generates stable voltage reference and bias currents foranalog circuits included in input/output circuit 54. Analog-to-digitalconverter (ADC) and multiplexer unit 84 digitizes analog signals andvoltages to provide “real-time” telemetry intracardiac signals andbattery end-of-life (EOL) replacement functions. Operating commands forcontrolling the timing of IMD 10 are coupled by data bus 72 to digitalcontroller/timer circuit 74, where digital timers and counters establishthe overall escape interval of the IMD 10 as well as various refractory,blanking and other timing windows for controlling the operation ofperipheral components disposed within input/output circuit 54.

[0054] Digital controller/timer circuit 74 is preferably coupled tosensing circuitry, including sense amplifier 88, peak sense andthreshold measurement unit 90 and comparator/threshold detector 92.Circuit 74 is further preferably coupled to electrogram (EGM) amplifier94 for receiving amplified and processed signals sensed by lead 18.Sense amplifier 88 amplifies sensed electrical cardiac signals andprovides an amplified signal to peak sense and threshold measurementcircuitry 90, which in turn provides an indication of peak sensedvoltages and measured sense amplifier threshold voltages on multipleconductor signal path 67 to digital controller/timer circuit 74. Anamplified sense amplifier signal is then provided tocomparator/threshold detector 92. By way of example, sense amplifier 88may correspond to that disclosed in U.S. Pat. No. 4,379,459 to Stein,hereby incorporated by reference herein in its entirety.

[0055] The electrogram signal provided by EGM amplifier 94 is employedwhen IMD 10 is being interrogated by an external programmer to transmita representation of a cardiac analog electrogram. See, for example, U.S.Pat. No. 4,556,063 to Thompson et al., hereby incorporated by referenceherein in its entirety. Output pulse generator 96 provides pacingstimuli to patient's heart 8 through coupling capacitor 98 in responseto a pacing trigger signal provided by digital controller/timer circuit74 each time the escape interval times out, an externally transmittedpacing command is received or in response to other stored commands as iswell known in the pacing art. By way of example, output amplifier 96 maycorrespond generally to an output amplifier disclosed in U.S. Pat. No.4,476,868 to Thompson, hereby incorporated by reference herein in itsentirety.

[0056] The specific embodiments of input amplifier 88, output amplifier96 and EGM amplifier 94 identified herein are presented for illustrativepurposes only, and are not intended to be limiting in respect of thescope of the present invention. The specific embodiments of suchcircuits may not be critical to practicing some embodiments of thepresent invention so long as they provide means for generating astimulating pulse and are capable of providing signals indicative ofnatural or stimulated contractions of heart 8.

[0057] In some preferred embodiments of the present invention, IMD 10may operate in various non-rate-responsive modes, including, but notlimited to, DDD, DDI, VVI, VOO and VVT modes. In other preferredembodiments of the present invention, IMD 10 may operate in variousrate-responsive modes, including, but not limited to, DDDR, DDIR, VVIR,VOOR and VVTR modes. Some embodiments of the present invention arecapable of operating in both non-rate-responsive and rate responsivemodes. Moreover, in various embodiments of the present invention IMD 10may be programmably configured to operate so that it varies the rate atwhich it delivers stimulating pulses to heart 8 only in response to oneor more selected sensor outputs being generated. Numerous pacemakerfeatures and functions not explicitly mentioned herein may beincorporated into IMD 10 while remaining within the scope of the presentinvention.

[0058] The present invention is not limited in scope to single-sensor ordual-sensor pacemakers, and is not limited to IMD's comprising activityor pressure sensors only. Nor is the present invention limited in scopeto single-chamber pacemakers, single-chamber leads for pacemakers orsingle-sensor or dual-sensor leads for pacemakers. Thus, variousembodiments of the present invention may be practiced in conjunctionwith more than two leads or with multiple-chamber pacemakers, forexample. At least some embodiments of the present invention may beapplied equally well in the contexts of single-, dual-, triple- orquadruple- chamber pacemakers or other types of IMD's. See, for example,U.S. Pat. No. 5,800,465 to Thompson et al., hereby incorporated byreference herein in its entirety, as are all U.S. Patents referencedtherein.

[0059] IMD 10 may also be a pacemaker-cardioverter- defibrillator(“PCD”) corresponding to any of numerous commercially availableimplantable PCD's. Various embodiments of the present invention may bepracticed in conjunction with PCD's such as those disclosed in U.S. Pat.No. 5,545,186 to Olson et al., U.S. Pat. No. 5,354,316 to Keimel, U.S.Pat. No. 5,314,430 to Bardy, U.S. Pat. No. 5,131,388 to Pless and U.S.Pat. No. 4,821,723 to Baker et al., all hereby incorporated by referenceherein, each in its respective entirety.

[0060]FIGS. 4 and 5 illustrate one embodiment of IMD 10 and acorresponding lead set of the present invention, where IMD 10 is a PCD.In FIG. 4, the ventricular lead takes the form of leads disclosed inU.S. Pat. Nos. 5,099,838 and 5,314,430 to Bardy, and includes anelongated insulative lead body 1 carrying three concentric coiledconductors separated from one another by tubular insulative sheaths.Located adjacent the distal end of lead 1 are ring electrode 2,extendable helix electrode 3 mounted retractably within insulativeelectrode head 4 and elongated coil electrode 5. Each of the electrodesis coupled to one of the coiled conductors within lead body 1.Electrodes 2 and 3 are employed for cardiac pacing and for sensingventricular depolarizations. At the proximal end of the lead isbifurcated connector 6 which carries three electrical connectors, eachcoupled to one of the coiled conductors. Defibrillation electrode 5 maybe fabricated from platinum, platinum alloy or other materials known tobe usable in implantable defibrillation electrodes and may be about 5 cmin length.

[0061] The atrial/SVC lead shown in FIG. 4 includes elongated insulativelead body 7 carrying three concentric coiled conductors separated fromone another by tubular insulative sheaths corresponding to the structureof the ventricular lead. Located adjacent the J-shaped distal end of thelead are ring electrode 9 and extendable helix electrode 13 mountedretractably within an insulative electrode head 15. Each of theelectrodes is coupled to one of the coiled conductors within lead body7. Electrodes 13 and 9 are employed for atrial pacing and for sensingatrial depolarizations. Elongated coil electrode 19 is provided proximalto electrode 9 and coupled to the third conductor within lead body 7.Electrode 19 preferably is 10 cm in length or greater and is configuredto extend from the SVC toward the tricuspid valve. In one embodiment ofthe present invention, approximately 5 cm of the right atrium/SVCelectrode is located in the right atrium with the remaining 5 cm locatedin the SVC. At the proximal end of the lead is bifurcated connector 17carrying three electrical connectors, each coupled to one of the coiledconductors.

[0062] The coronary sinus lead shown in FIG. 4 assumes the form of acoronary sinus lead disclosed in the above cited '838 patent issued toBardy, and includes elongated insulative lead body 41 carrying onecoiled conductor coupled to an elongated coiled defibrillation electrode21. Electrode 21, illustrated in broken outline in FIG. 4, is locatedwithin the coronary sinus and great vein of the heart. At the proximalend of the lead is connector plug 23 carrying an electrical connectorcoupled to the coiled conductor. The coronary sinus/great vein electrode41 may be about 5 cm in length.

[0063] Implantable PCD 10 is shown in FIG. 4 in combination with leads1, 7 and 41, and lead connector assemblies 23, 17 and 6 inserted intoconnector block 12. Optionally, insulation of the outward facing portionof housing 14 of PCD 10 may be provided using a plastic coating such asparylene or silicone rubber, as is employed in some unipolar cardiacpacemakers. The outward facing portion, however, may be left uninsulatedor some other division between insulated and uninsulated portions may beemployed. The uninsulated portion of housing 14 serves as a subcutaneousdefibrillation electrode to defibrillate either the atria or ventricles.Lead configurations other that those shown in FIG. 4 may be practiced inconjunction with the present invention, such as those shown in U.S. Pat.No. 5,690,686 to Min et al., hereby incorporated by reference herein inits entirety.

[0064]FIG. 5 is a functional schematic diagram of one embodiment ofimplantable PCD 10 of the present invention. This diagram should betaken as exemplary of the type of device in which various embodiments ofthe present invention may be embodied, and not as limiting, as it isbelieved that the invention may be practiced in a wide variety of deviceimplementations, including cardioverter and defibrillators which do notprovide anti-tachycardia pacing therapies.

[0065] IMD 10 is provided with an electrode system. If the electrodeconfiguration of FIG. 4 is employed, the correspondence to theillustrated electrodes is as follows. Electrode 25 in FIG. 5 includesthe uninsulated portion of the housing of PCD 10. Electrodes 25, 15, 21and 5 are coupled to high voltage output circuit 27, which includes highvoltage switches controlled by CV/defib control logic 29 via control bus31. Switches disposed within circuit 27 determine which electrodes areemployed and which electrodes are coupled to the positive and negativeterminals of the capacitor bank (which includes capacitors 33 and 35)during delivery of defibrillation pulses.

[0066] Electrodes 2 and 3 are located on or in the ventricle and arecoupled to the R-wave amplifier 37, which preferably takes the form ofan automatic gain controlled amplifier providing an adjustable sensingthreshold as a function of the measured R-wave amplitude. A signal isgenerated on R-out line 39 whenever the signal sensed between electrodes2 and 3 exceeds the present sensing threshold.

[0067] Electrodes 9 and 13 are located on or in the atrium and arecoupled to the P-wave amplifier 43, which preferably also takes the formof an automatic gain controlled amplifier providing an adjustablesensing threshold as a function of the measured P-wave amplitude. Asignal is generated on P-out line 45 whenever the signal sensed betweenelectrodes 9 and 13 exceeds the present sensing threshold. The generaloperation of R-wave and P-wave amplifiers 37 and 43 may correspond tothat disclosed in U.S. Pat. No. 5,117,824, by Keimel et al., issued Jun.2, 1992, for “An Apparatus for Monitoring Electrical PhysiologicSignals”, hereby incorporated by reference herein in its entirety.

[0068] Switch matrix 47 is used to select which of the availableelectrodes are coupled to wide band (0.5-200 Hz) amplifier 49 for use indigital signal analysis. Selection of electrodes is controlled by themicroprocessor 51 via data/address bus 53, which selections may bevaried as desired. Signals from the electrodes selected for coupling tobandpass amplifier 49 are provided to multiplexer 55, and thereafterconverted to multi-bit digital signals by A/ID converter 57, for storagein random access memory 59 under control of direct memory access circuit61. Microprocessor 51 may employ digital signal analysis techniques tocharacterize the digitized signals stored in random access memory 59 torecognize and classify the patient's heart rhythm employing any of thenumerous signal processing methodologies known in the art.

[0069] The remainder of the circuitry is dedicated to the provision ofcardiac pacing, cardioversion and defibrillation therapies, and, forpurposes of the present invention may correspond to circuitry known tothose skilled in the art. The following exemplary apparatus is disclosedfor accomplishing pacing, cardioversion and defibrillation functions.Pacer timing/control circuitry 63 preferably includes programmabledigital counters which control the basic time intervals associated withDDD, VVI, DVI, VDD, AAI, DDI and other modes of single and dual chamberpacing well known in the art. Circuitry 63 also preferably controlsescape intervals associated with anti-tachyarrhythmia pacing in both theatrium and the ventricle, employing any anti-tachyarrhythmia pacingtherapies known to the art.

[0070] Intervals defined by pacing circuitry 63 include atrial andventricular pacing escape intervals, the refractory periods during whichsensed P-waves and R-waves are ineffective to restart timing of theescape intervals and the pulse widths of the pacing pulses. Thedurations of these intervals are determined by microprocessor 51, inresponse to stored data in memory 59 and are communicated to pacingcircuitry 63 via address/data bus 53. Pacer circuitry 63 also determinesthe amplitude of the cardiac pacing pulses under control ofmicroprocessor 51.

[0071] During pacing, escape interval counters within pacertiming/control circuitry 63 are reset upon sensing of R-waves andP-waves as indicated by a signals on lines 39 and 45, and in accordancewith the selected mode of pacing on time-out trigger generation ofpacing pulses by pacer output circuitry 65 and 67, which are coupled toelectrodes 9, 13, 2 and 3. Escape interval counters are also reset ongeneration of pacing pulses and thereby control the basic timing ofcardiac pacing functions, including anti-tachyarrhythmia pacing. Thedurations of the intervals defined by escape interval timers aredetermined by microprocessor 51 via data/address bus 53. The value ofthe count present in the escape interval counters when reset by sensedR-waves and P-waves may be used to measure the durations of R-Rintervals, P-P intervals, P-R intervals and R-P intervals, whichmeasurements are stored in memory 59 and used to detect the presence oftachyarrhythmias.

[0072] Microprocessor 51 most preferably operates as an interrupt drivendevice, and is responsive to interrupts from pacer timing/controlcircuitry 63 corresponding to the occurrence sensed P-waves and R-wavesand corresponding to the generation of cardiac pacing pulses. Thoseinterrupts are provided via data/address bus 53. Any necessarymathematical calculations to be performed by microprocessor 51 and anyupdating of the values or intervals controlled by pacer timing/controlcircuitry 63 take place following such interrupts.

[0073] Detection of atrial or ventricular tachyarrhythmias, as employedin the present invention, may correspond to tachyarrhythmia detectionalgorithms known in the art. For example, the presence of an atrial orventricular tachyarrhythmia may be confirmed by detecting a sustainedseries of short R-R or P-P intervals of an average rate indicative oftachyarrhythmia or an unbroken series of short R-R or P-P intervals. Thesuddenness of onset of the detected high rates, the stability of thehigh rates, and a number of other factors known in the art may also bemeasured at this time. Appropriate ventricular tachyarrhythmia detectionmethodologies measuring such factors are described in U.S. Pat. No.4,726,380 issued to Vollmann, U.S. Pat. No. 4,880,005 issued to Pless etal. and U.S. Pat. No. 4,830,006 issued to Haluska et al., allincorporated by reference herein, each in its respective entirety. Anadditional set of tachycardia recognition methodologies is disclosed inthe article “Onset and Stability for Ventricular TachyarrhythmiaDetection in an Implantable Pacer-Cardioverter-Defibrillator” by Olsonet al., published in Computers in Cardiology, Oct. 7-10, 1986, IEEEComputer Society Press, pages 167-170, also incorporated by referenceherein in its entirety. Atrial fibrillation detection methodologies aredisclosed in Published PCT Application Ser. No. US92/02829, PublicationNo. WO92/18198, by Adams et al., and in the article “AutomaticTachycardia Recognition”, by Arzbaecher et al., published in PACE,May-June, 1984, pp. 541-547, both of which are incorporated by referenceherein in their entireties.

[0074] In the event an atrial or ventricular tachyarrhythmia is detectedand an anti-tachyarrhythmia pacing regimen is desired, appropriatetiming intervals for controlling generation of anti-tachyarrhythmiapacing therapies are loaded from microprocessor 51 into the pacer timingand control circuitry 63, to control the operation of the escapeinterval counters therein and to define refractory periods during whichdetection of R-waves and P-waves is ineffective to restart the escapeinterval counters.

[0075] Alternatively, circuitry for controlling the timing andgeneration of anti-tachycardia pacing pulses as described in U.S. Pat.No. 4,577,633, issued to Berkovits et al. on Mar. 25, 1986, U.S. Pat.No. 4,880,005, issued to Pless et al. on Nov. 14, 1989, U.S. Pat. No.4,726,380, issued to Vollmann et al. on Feb. 23, 1988 and U.S. Pat. No.4,587,970, issued to Holley et al. on May 13, 1986, all of which areincorporated herein by reference in their entireties, may also beemployed.

[0076] In the event that generation of a cardioversion or defibrillationpulse is required, microprocessor 51 may employ an escape intervalcounter to control timing of such cardioversion and defibrillationpulses, as well as associated refractory periods. In response to thedetection of atrial or ventricular fibrillation or tachyarrhythmiarequiring a cardioversion pulse, microprocessor 51 activatescardioversion/defibrillation control circuitry 29, which initiatescharging of the high voltage capacitors 33 and 35 via charging circuit69, under the control of high voltage charging control line 71. Thevoltage on the high voltage capacitors is monitored via VCAP line 73,which is passed through multiplexer 55 and in response to reaching apredetermined value set by microprocessor 51, results in generation of alogic signal on Cap Full (CF) line 77 to terminate charging. Thereafter,timing of the delivery of the defibrillation or cardioversion pulse iscontrolled by pacer timing/control circuitry 63. Following delivery ofthe fibrillation or tachycardia therapy microprocessor 51 returns thedevice to q cardiac pacing mode and awaits the next successive interruptdue to pacing or the occurrence of a sensed atrial or ventriculardepolarization.

[0077] Several embodiments of appropriate systems for the delivery andsynchronization of ventricular cardioversion and defibrillation pulsesand for controlling the timing functions related to them are disclosedin U.S. Pat. No. 5,188,105 to Keimel, U.S. Pat. No. 5,269,298 to Adamset al. and U.S. Pat. No. 4,316,472 to Mirowski et al., herebyincorporated by reference herein, each in its respective entirety. Anyknown cardioversion or defibrillation pulse control circuitry isbelieved to be usable in conjunction with various embodiments of thepresent invention, however. For example, circuitry controlling thetiming and generation of cardioversion and defibrillation pulses such asthat disclosed in U.S. Pat. No. 4,384,585 to Zipes, U.S. Pat. No.4,949,719 to Pless et al., or U.S. Pat. No. 4,375,817 to Engle et al.,all hereby incorporated by reference herein in their entireties, mayalso be employed.

[0078] Continuing to refer to FIG. 5, delivery of cardioversion ordefibrillation pulses is accomplished by output circuit 27 under thecontrol of control circuitry 29 via control bus 31. Output circuit 27determines whether a monophasic or biphasic pulse is delivered, thepolarity of the electrodes and which electrodes are involved in deliveryof the pulse. Output circuit 27 also includes high voltage switcheswhich control whether electrodes are coupled together during delivery ofthe pulse. Alternatively, electrodes intended to be coupled togetherduring the pulse may simply be permanently coupled to one another,either exterior to or interior of the device housing, and polarity maysimilarly be pre-set, as in current implantable defibrillators. Anexample of output circuitry for delivery of biphasic pulse regimens tomultiple electrode systems may be found in the above cited patent issuedto Mehra and in U.S. Pat. No. 4,727,877, hereby incorporated byreference herein in its entirety.

[0079] An example of circuitry which may be used to control delivery ofmonophasic pulses is disclosed in U.S. Pat. No. 5,163,427 to Keimel,also incorporated by reference herein in its entirety. Output controlcircuitry similar to that disclosed in U.S. Pat. No. 4,953,551 to Mehraet al. or U.S. Pat. No. 4,800,883 to Winstrom, both incorporated byreference herein in their entireties, may also be used in conjunctionwith various embodiments of the present invention to deliver biphasicpulses.

[0080] Alternatively, IMD 10 may be any type of implantable medicaldevice, including, but not limited to, an implantable nerve stimulatoror muscle stimulator such as those disclosed in U.S. Pat. No. 5,199,428to Obel et al., U.S. Pat. No. 5,207,218 to Carpentier et al. and U.S.Pat. No. 5,330,507 to Schwartz, an implantable monitoring device such asthat disclosed in U.S. Pat. No. 5,331,966 issued to Bennet et al., animplantable brain stimulator, an implantable gastric system stimulator,an implantable vagus nerve stimulator, an implantable lower colonstimulator (e.g., in graciloplasty applications), an implantable drug orbeneficial agent dispenser or pump, an implantable cardiac signal loopor other type of recorder or monitor, an implantable gene therapydelivery device, an implantable incontinence prevention or monitoringdevice, an implantable insulin pump or monitoring device, and so on.Thus, the present invention is believed to find wide application inconjunction with almost any appropriately adapted implantable medicaldevice.

[0081]FIGS. 6A, 6B and 6C show simplified schematic and flow diagrams ofvarious embodiments of the principal communications components of thepresent invention. It is to be understood that the term “remote system”employed in the specification and claims hereof includes within itsscope the terms “remote computer”, “remote computer system”, “remotecomputer network”, “remote expert data center”, “remote data resourcesystem”, “data resource system”, and like terms. It is further to benoted that the term “remote health care provider” employed in thespecification and claims hereof includes within its scope the terms“physician”, “field clinical engineering representative”, “remoteauthorized user”, “operator”, “remote user”, “database specialist,”“clinical specialist,” “nurse,” “computer specialist”, “remoteoperator”, “remote user” and like terms, and that the term “remotesystem” encompasses the foregoing terms.

[0082] Referring now to FIGS. 6A and 7, there is shown a simplifiedschematic diagram of the major components of the present inventioncomprising IMD 10, communication module 100, mobile telephone 110,telephone/Internet communications network 120, and remote computer orremote health care provider 130. In the embodiment of the presentinvention illustrated in FIGS. 6A and 8, communication module 100 isdisposed within housing 102 and is connected by a suitable interface tomobile telephone 110 via link, connection, cable or line 107. Hardwiredlink, connection, cable or line 107 may be replaced with a wirelesslink, as discussed in further detail below. Via link 107 or othersuitable means, mobile telephone 110 receives information or data from,or sends information or data to, communication module 100. IMD 10receives information or data from, or sends information or data to,communication module 100, most preferably via RF telemetric meansdiscussed in further detail below. Thus, communication module 100 actsas a go-between in respect of mobile telephone 100 and IMD 10. In someembodiments of the present invention, communication module 100 andmobile telephone supplant, eliminate or reduce the requirement for aconventional implantable medical device programmer such as a MEDTRONIC9790 Programmer to communicate with IMD 10.

[0083] The hardware and/or software of communication module 100 may beconfigured to operate in conjunction with a plurality of differentimplantable medical devices 10. The particular type of IMD 10 to becommunicated with may be pre-programmed in module 100, or may beselected before or at the time IMD is to be communicated with. Forexample, communication module 10 may be selectably configured orpre-programmed or configured to communicate with, receive data from,and/or download data to any of the various commercially available IMDsmanufactured and sold by MEDTRONIC, BIOTRONIK, CARDIAC PACEMAKERS,GUIDANT, ELA, SIEMENS, SORIN, NEUROCOR, ADVANCED NEUROLOGICAL SYSTEMS,CYBERONICS and/or TERUMO using telemetry communication protocols andtechniques well known in the art.

[0084] Communication system 120 includes within its scope the existingworldwide telephone and Internet communications network, as well asfuture embodiments thereof. Communication system 120 permitscommunication module 100/mobile telephone or PDA 110 to communicate withremote system 130 via communication system 120.

[0085] Remote system 130 may comprise any one or more of remote computersystem 130, remote computer system 131′, remote health care provider,physician, database specialist, clinical specialist, nurse, computerspecialist and/or operator 136, and/or remote physician 135. In additionto being capable of communicating with communication module 100/mobiletelephone or PDA 110 via communication system 120, remote computersystem 131 may communicate with directly with computer system 131′and/or remote health care provider, physician, database specialist,clinical specialist, nurse, computer specialist and/or operator 136through link 139, or through links 137 and 137′ via communication system120.

[0086] Remote computer system 131 may also be configured to communicatedirectly with physician 135, or to communicate with physician 135 vialinks 137 and 137″ through communication system 120. Computer system131′ and/or remote health care provider, physician, database specialist,clinical specialist, nurse, computer specialist or operator 136 may alsocommunicate with physician 130 directly through link 139′, or throughlinks 137′ and 137″ via communication system 120.

[0087] It will now become clear to those skilled in the art uponconsidering the present disclosure that many different permutations andcombinations of any pair or more of communication module 100, mobiletelephone 110, communication system 120, remote computer system 131,remote computer system 131′, remote health care provider, physician,database specialist, clinical specialist, nurse, computer specialistand/or operator 136, physician 135, and links 137, 137′, 137″, 139 and139′ are possible, all of which are intended to fall within the scope ofthe present invention.

[0088]FIG. 6C shows simple flow diagrams corresponding to one method ofthe present invention where IMD 10, communication module 100/mobiletelephone or PDA 110 and remote system 130 communicate with another viacommunication system 120. IMD 10 may monitor various aspects of thepatient's health, and store same in memory as information or data. UponIMD 10 detecting a threshold event (e.g., detection of arrhythmia orfibrillation in patient 5) or receiving instruction from patient 5 orremote system 130, IMD may upload stored information or data to remotesystem 130 via communication module 100, mobile telephone 110 andcommunication system 130. IMD 10 may be interrogated directly by patient5, or may be interrogated remotely by remote system 130 viacommunication module 100 and mobile telephone 110. The system of thepresent invention may also include provisions for determining thegeographical location of the patient using mobile cell telephonelocation data or by incorporating or otherwise operably connecting aGlobal Positioning System (GPS) module into communication module 100 ormobile telephone 110.

[0089] In one embodiment of the present invention, IMD automaticallycontacts remote system 130 via communication module 100 and mobiletelephone 110 in response to detecting a life-threatening or seriouscondition in the patient's health. In response to receiving informationconcerning the detected condition from IMD 10, remote system 130 may beemployed to automatically or under the supervision of health careprovider 135 or 136 provide an appropriate response, such as thedelivery of instructions to IMD 10 to deliver a specific therapy oralerting an emergency, ambulance or paramedic service to proceedimmediately to the location of patient 5. As discussed above, thepatient's specific location may be provided by various means, such asGPS or mobile telephone cell location identification information.

[0090] In another embodiment of the present invention, patient 5 sensesa physiologic event and is sufficiently concerned respecting same tomanipulate user interface 108 to cause data already uploaded into thememory of communication module 100 (or data uploaded into the memory ofcommunication module 100 in response to the patient's manipulation ofinterface 108) to be relayed to remote system 130 for analysis andfurther action or response. In response to receiving informationconcerning the patient's health status from communication module 100,remote system 130 may be employed to automatically or under thesupervision of health care provider 135 or 136 provide an appropriateresponse, such as the delivery of instructions to IMD 10 to deliver aspecific therapy or alerting an emergency, ambulance or paramedicservice to proceed immediately to the location of patient 5. Once again,the patient's specific location may be provided by various means, suchas GPS or mobile telephone cell location identification information.

[0091]FIG. 7 shows some basic components of communication module 100according to one embodiment of the present invention. Communicationmodule 100 preferably comprises microprocessor, CPU, micro-computer orcontroller 104 for controlling the operation of module 100 and theexchange of data and information between IMD 10 and mobile telephone110, telemetry module 101 for communicating with IMD 10, memory/storagemodule 105 for storing or recalling information or data in memory, ahard disk, or another computer readable medium such as flash memory,ROM, RAM, EEPROM, and the like, power management module 106 formonitoring the state of charge and/or controlling the discharge of abattery located in mobile telephone 110 or in communication module 100,real time clock 109 for providing timing signals to computing andcontrolling device 104, and display and/or user interface 108.

[0092] Referring now to FIGS. 6A and 7, electronics disposed withincommunication module 100 are most preferably electrically powered by oneor more primary or secondary (i.e., rechargeable) batteries disposedwithin or attached to mobile telephone 110 using line or cord 108.Communication module 100 may also be powered by such batteries disposedwithin housing 102, other portable energy sources, solar panels,capacitors, supercapacitors, appropriately filtered and rectifiedhousehold line ac power, or any other suitable power source. Powermanagement module 106 is preferably configured to minimize current drainfrom whatever battery it is that is being employed to powercommunication module 100 by utilizing wake-up mode and sleep modeschemes well known in the implantable medical device and mobiletelephone arts. Power management module 106 may also be configured topermit communication module 100 to be powered electrically by its owninternal battery or the battery of the mobile telephone in accordancewith a priority scheme assigned to the use of those batteries. Thus, ifone battery's state of charge becomes too low, power management module106 may be configured to switch to the remaining battery as anelectrical power source for communication module 100 and/or mobiletelephone 110.

[0093] Interface 103 may be any suitable interface, such as a serial orparallel interface. Cable or line 107 may include or be combined withline or cord 108. In a preferred embodiment of the present invention,the end of line 107 that attaches to mobile telephone 110 comprises astandardized connector which plugs directly into a correspondingstandardized or manufacturer-specific connectors for such as theconnectors found in many off-the-shelf, unmodified,commercially-available mobile telephones or PDAs. In another embodimentof the present invention, and as discussed in further detail below,communication module 100 and mobile telephone 110 communicate wirelesslyby, for example, RF, optical or infrared means and are not physicallyconnected to one another.

[0094] As shown in FIG. 6B, communication module 100 may be incorporatedinto or attached directly to the housing of mobile telephone 110. In onesuch embodiment of the present invention, at least portions of theexterior housing of an off-the-shelf mobile telephone, PDA and/orcombined mobile telphone/PDA are modified to permit communication module100 to be integrated into mobile telephone or PDA 110 such that mobiletelephone or PDA 110 and communication module 100 form a single physicalunit, thereby lending increased portability to the communication moduleof the present invention. Communication module 100 and mobile telephoneor PDA 110 may also be configured and shaped such that module 100 clipsonto or otherwise attaches to mobile telephone 110 in a detachable,semi-permanent or other manner. Although not shown explicitly in FIG. 6Bor the other Figures, in the present invention it is of coursecontemplated that mobile telephone or PDA 110 communicate with remotesystem 130 via communication system 120, where communication system 120most preferably includes towers, transmitter, dishes, fiber opticcables, conventional hard wiring, RF links, transponders and otherreception and transmission devices capable of relaying or transpondingsignals received from or sent to mobile phone or PDA 110.

[0095] In still another embodiment of the present invention, anoff-the-shelf mobile telephone or PDA 110 may be modified such that onlya limited number of buttons having predetermined functions are presentedto and available for patient 5 to push. For example, such a modifiedmobile telephone could present patient 5 with one or more of “emergency911 alert”, “acquire IMD status”, “acquire patient health status”, or“contact health care provider” buttons, which when pressed willthereafter automatically execute the indicated instruction. Otherbuttons might not be provided on such a modified mobile telephone toavoid confusing patient 5. Similarly, such a limited number of buttonshaving predetermined functions could be incorporated into communicationmodule 100, into combined mobile telephone 110/communication module 100,or into a mobile telephone adapted for use by physician 135 or remotehealth care provider 136 in the system of the present invention.

[0096] As shown in FIG. 7, communication module 100 may include optionaldisplay and/or user interface 108 for conveying certain information toor from patient 5. Such information may include, without limitation, thecurrent performance status of IMD 10, the patient's current healthstatus, confirmation that an operation is being carried out or has beenexecuted by module 100 or mobile telephone 110, indication that a healthcare provider is attempting to communicate or is communicating withpatient 5, communication module 100 or IMD, indication that successfultelemetry communication between IMD 10 and module 100 is in progress,and the like. Display and/or user interface 108 may comprise, by way ofexample only, one or more LEDs, an LCD, a CRT, a plasma screen, anyother suitable display device known in the mobile telephone, implantablemedical device, computer, consumer appliance, consumer product or otherarts. Display and/or user interface 108 may also comprise, by way ofexample only, a keyboard, push-buttons, a touch panel, a touch screen,or any other suitable user interface mechanism known in the mobiletelephone, implantable medical device, computer, consumer appliance,consumer product or other arts.

[0097] Referring now to FIGS. 6A and 7, communication module 100preferably communicates with mobile telephone 110 via mobile telephoneinterface 103 and line or connection 107 using standardized serialcommunication protocols and hardware and/or software controlledhandshakes associated with RS-232 connectors (although othercommunication protocols and handshakes may certainly be employed in thepresent invention, including those which utilize parallel communicationinterfaces). Interface 103 may comprise a PCMCIA (Personal ComputerMemory Card International Association) modem card interface forcommunication between communication module 100 and mobile telephone 110.For example, interface 103 may comprise a standard PCMCIA plug-and-play56 kbaud modem card adapted to be connected to mobile telephone 110using a serial or parallel connecting cable of the type well known inthe mobile telephone and computer arts.

[0098] Communication module 100 may also be adapted to receive othertypes of PCMCIA cards, such as data storage cards and data memory cardsfor memory/storage module 105, display cards for display 108, and so on.PCMCIA cards suitable for use in various embodiments of the presentinvention may be PCMCIA Type I cards up to 3.3 mm thick (used primarilyfor adding additional ROM or RAM to a communication module 100), PCMCIAType II cards up to 5.5 mm thick (used primarily for modem and fax modemcards), and PCMCIA Type III cards up to 10.5 mm thick (sufficientlylarge for portable disk drives). Various types of PCMCIA slots may alsobe disposed in communication module 100 to receive the foregoing PCMCIAcards, including Type I slots, Type II slots, and Type III slots.

[0099] In another embodiment of the present invention, communicationmodule 100 and mobile telephone 110 may not be physically connected toone another by a data line or cord 107, and instead communicatewirelessly through, by way of example only, RF or infrared means.Likewise, antenna or coil 101 may be separate or detachable fromcommunication module and be capable of communicating wirelessly withcommunication module 100.

[0100] Wireless communication between at least some components of thecommunication system of the present invention located near, on or inpatient 5 may be accomplished or assisted using devices which conform tothe BLUETOOTH standard, a 2.4 GHz wireless technology employed totransport data between cellular phones, notebook PCs, and other handheldor portable electronic gear at speeds of up to 1 megabit per second. TheBLUETOOTH standard was developed by the Bluetooth Special Interest Group(or “BSIG”), a consortium formed by Ericsson, IBM, Intel, Nokia andToshiba. The BLUETOOTH standard is designed to be broadband compatible,and capable of simultaneously supporting multiple information sets andarchitecture, transmitting data at relatively high speeds, and providingdata, sound and video services on demand. Of course, other suitablewireless communication standards and methods now existing or developedin future are contemplated in the present invention. It is to be notedthat under some circumstances difficulty will be encountered employingBLUETOOTH technology for communication with implantable medical devicesowing to the relatively high power requirements of the system.Additionally, in the present invention it is contemplated that variousembodiments operate in conjunction with a BLUETOOTH or BLUETOOTH-likewireless communication standard, protocol or system where a frequencyother than 2.4 GHz is employed, or where infra-red, optical or othercommunication means are employed in at least portions of the systems ofthe present invention and/or in conjunction with BLUETOOTH orBLUETOOTH-like wireless RF communication techniques.

[0101] One embodiment of the present invention using the BLUETOOTHstandard incorporates an RF device, a baseband controller, and flashmemory. One example of an RF BLUETOOTH device finding application in thepresent invention is the TEMIC SEMICONDUCTOR T2901 chip which enableswireless data to be transferred at distances of 10 meters, operates inthe 2.4-GHz frequency band, and has a power output of 0 dBm. Thebaseband controller may be a single-chip device that performslink-management and control functions, and based on an ARM 7TDMI, a32-bit RISC-chip core from ARM, LTD.

[0102] In one embodiment of the present invention, a plurality of IMDs10 may be implanted in patient 5 (see, for example, FIG. 8). It ispreferred that those IMDs be capable of capable of communicating withone another and/or with communication module 100 using, for example,conventional RF telemetry means, BLUETOOTH technology, or usingso-called “Body Bus” or “Body Wave” technology. See, for example, U.S.patent application Ser. No. 09/218,946 to Ryan et al. for “Telemetry forImplantable Devices Using the Body as an Antenna” (approximately 3 MHzcommunication); U.S. Pat. No. 5,113,859 to Funke et al. entitled“Acoustic Body Bus Medical Device Communication System”; and U.S. Pat.No. 4,987,897 to Funke et al. entitled “Body Bus Medical DeviceCommunication System”. Each of the foregoing patents and patentapplication is hereby incorporated by reference herein, each in itsrespective entirety.

[0103] Communication module 100 and microprocessor 104 may furtheroperate under a Microsoft Pocket PC, Windows 95, Windows 98, Windows2000, Windows CE, LINUX, UNIX, MAC, PalmOS, EPOC, EPOC16, EPOC32,FLEXOS, OS/9, JavaOS, SYMBIAN or other suitable computer operatingenvironment. Communication module 100 is further preferably configuredto accept interchangeable plug-and-play cards therein. For example,communication module 100 may be configured to accept differentplug-and-play cards for telemetry module 101, where each plug-and-playcard is particularly adapted to permit telemetry module 101 tocommunicate in an optimal fashion with a particular type or model of IMD10 implanted within patient 5. Thus, and by way of example only, onetype of plug-and-play card may be configured to communicate particularlywell with a certain model or range of models of a pacemaker, while othertypes of plug-and-play cards may be configured especially to communicatewith nerve stimulators, drug pumps or dispensers, gastric stimulators,PCDs, ICDs, and the like.

[0104] Reference is made to U.S. Pat. No. 5,701,894 to Cherry et al. fora “Modular Physiological Computer-Recorder”, hereby incorporated byreference herein in its entirety, where interchangeable plug and playsignal input conditioner cards are employed in conjunction with amicroprocessor system with analyzing software, and where a removablememory module for data storage is provided. Some concepts disclosed inthe '894 patent to Cherry, such as interchangeable plug-and-play cardsand removable memory modules, are adaptable for use in conjunction withcertain portions the present invention, such as communication module 100and microprocessor 104, memory/storage module 105, telemetry module 101,and the foregoing plug and play and/or PCMCIA cards that may beassociated therewith.

[0105] It is preferred that information, programming commands and/ordata be transmitted to IMD 10 by communication module 100, and thatinformation and data be received by communication module 100 from IMD10, using standard RF telemetry protocols and means well known in theart of implantable medical devices. For example, MEDTRONIC Telemetry A,B or C RF communication standards may be employed to effectcommunications between IMD 10 and communication module 100, and/orbetween IMD 10 and other IMDs implanted within patient 5. Alternatively,communication methods described in the foregoing '859 and '897 patentsto Funke and the '946 patent application to Ryan et al. may be employedto effect communications between IMD 10 and communication module 100,and/or between IMD 10 and other IMDs implanted within patient 5.

[0106] According to Telemetry A, B or C RF communication standards, RFcommunication occurs at frequencies of about 175 kHz, about 175 kHz andabout 400 MHz, respectively, with respective communication rangesbetween IMD 10 and communication module 100 of about 1″ to about 4″,about 1″ to about 4″, and about 1″ and about 20 feet. Communicationmodule 100 thus preferably comprises a telemetry antenna or coil 101,which may be an externally detachable RF head or equivalent well knownin the art, or which may be incorporated within housing 102. It ispreferred that communication module 100 be operative when placed withina few feet of patient 5 so that module 100 may communicate with IMD 10when patient 5, for example, is undergoing a treadmill test.Communication module 100 is preferably configured to permitcommunication according to the Telemetry A, B and C communicationstandards so that communication with a wide range of old, new and futuremodels and types of IMDs is possible.

[0107] Referring now to FIGS. 3, 6A and 7, antenna 56 of IMD 10 isconnected to input/output circuit 54 to permit uplink/downlink telemetrythrough RF transmitter and receiver telemetry unit 78. Informationand/or data are exchanged between IMD 10 and communication module 100 bymeans of an antenna or coil forming a part of telemetry module 101 incommunication module 100 and antenna 56 disposed in IMD 10. Telemetrymodule 101 may feature a detachable RF head comprising a coil or antennaof the type well known in the implantable medical device arts.Alternatively, the coil or antenna of telemetry module 100 may beincorporated into communication module 100 such that module 100 iscontained within a single housing, or within the housing of mobiletelephone 110.

[0108] Telemetry module 101 preferably comprises an external RFtelemetry antenna coupled to a telemetry transceiver and antenna drivercircuit board which includes a telemetry transmitter and telemetryreceiver. The telemetry transmitter and telemetry receiver arepreferably coupled to control circuitry and registers operated under thecontrol of computing and control device 104. Similarly, within IMD 10,RF telemetry antenna 56 is coupled to a telemetry transceiver comprisingRF telemetry transmitter and receiver circuit 78. Circuit 78 in IMD 10is coupled to control circuitry and registers operated under the controlof microcomputer circuit 58.

[0109] According to one embodiment of the present invention, telemetrycoil or antenna 101 may be incorporated into a belt, harness, strap,bandage, or article of clothing which the patient wears and thatpositions coil or antenna of telemetry module 101 directly over orotherwise in close proximity to the patient's heart 8 to thereby providesuitable RF coupling between IMD 10 and communication module 100. Insuch an embodiment of the present invention, communication module 100may be attached to patient 5 along with mobile telephone 110 using, byway of example only, a belt or fanny pack, while coil or antenna oftelemetry module 101 is attached to module 100 using a suitable wire orcord, thereby permitting the patient considerable freedom of movement.See, for example, Provisional U.S. Patent Appln. Ser. No. 60/197,753 for“ECG and RF Apparatus for Medical Device Systems” filed Apr. 19, 2000and corresponding U.S. patent appln. Ser. No. 09/696,319 filed Oct. 25,2000 for “Method and Apparatus for Communicating with Medical DeviceSystems” to Pool et al., the respective entireties of which are herebyincorporated by reference herein.

[0110] As discussed above, uplinking of IMD 10 to, or downlinking to IMD10 from, remote system 130 may be effected through mobile telephone orPDA 110 and telephone/Internet communications network or communicationsystem 120. Accordingly, communication module 100, mobile telephone 110and communication system 120 function as an interface between IMD 10 andremote computer system 130.

[0111] Communication module 100 may also be configured to permit a dualuplinking capability, where module 100 is capable of uplinking dataand/or information both to mobile telephone 110 and to a standardimplantable medical device programmer (not shown in the Figures), suchas a MEDTRONIC 9790 Programmer or a programmer of the type disclosed inU.S. Pat. No. 5,345,362 to Winkler, hereby incorporated by referenceherein in its entirety. Thus, in such an embodiment of the presentinvention, IMD 10 may be communicated with remotely in accordance withthe methods and devices of the present invention, or may be communicatedwith conventional fashion, according to the patient's and health careprovider's needs at any particular time.

[0112] One feature of the present invention is the use of variousscalable, reliable and high-speed wireless or other communicationsystems in communication system 120 to bi-directionally transmit highfidelity digital and/or analog data between communication module 100 andremote system 130. A variety of wireless and other suitable transmissionand reception systems and combinations thereof may be employed to helpestablish data communications between communication module 100 andremote system 130, such as, without limitation, stationary microwaveantennas, fiber optic cables, conventional above-ground and undergroundtelephone cables and RF antennas well known in the art of mobiletelephony.

[0113] As discussed above, remote system 130 and communication module100 are linked by mobile telephone 110 and communication system 120. Inone embodiment of the present invention, communication system 120comprises a GSM network system comprising a mobile station carried bythe patient, a base station subsystem for controlling the radio linkwith the mobile station, and a network subsystem (the main part of whichis a mobile services switching center which performs the switching ofcalls between the mobile and other fixed or mobile network users, aswell as management of mobile services, such as authentication), and anoperations and maintenance center which oversees the proper operationand setup of the network. The GSM mobile station and the base stationsubsystem communicate across an air interface or radio link. The basestation subsystem communicates with the mobile service switching centeracross another interface.

[0114] Examples of telephone, computer and mobile telephonecommunication air interface standards, protocols and communicationsystems that may be employed in conjunction with communication module100, mobile telephone 110, communication system 120, and remote system130 of the present invention include, but are in no way limited to thefollowing:

[0115] ATM;

[0116] AXE;

[0117] AMPS (Advanced Mobile Phone Service);

[0118] CDMA (Code Division Multiple Access);

[0119] DECT (Digital Enhanced Cordless Telecommunication);

[0120] Dual-mode combined mobile satellite and cellular standards(employed by such Mobile Satellite Services (MSSs) such as Immarsat,Odyssey, Globalstar, Teledesic, ICO, Thuyra, ACes, Agrani, EAST and thenow defunct Iridium system).

[0121] GSM (Geostationary Satellite Standard);

[0122] GMSS (Geostationary Mobile Satellite Standard);

[0123] GPRS (General Packet Radio Service—a standard for wirelesscommunications which runs at speeds up to 150 kilobits per second,compared with current GSM systems' 9.6 kilobits per second—whichsupports a wide range of bandwidths and is particularly suited forsending and receiving small bursts of data, such as e-mail and Webbrowsing, as well as large volumes of data; see, for example, Japan'sNTT DoCoMo I-mode system);

[0124] IMEI (International Mobile Equipment Identity—a unique numbergiven to every mobile phone and stored in a database—the EIR orEquipment Identity Register—containing all valid mobile phone equipment;when a phone is reported stolen or is not type approved, the number ismarked invalid);

[0125] I-Mode (Japanese NTT DoCoMo Inc. system and protocol forpermitting internet access via mobile telephones)

[0126] IP Telephony Standards and communication systems; and

[0127] MOBITEX Virtual Private Networking;

[0128] MOEBIUS (Mobile Extranet Based Integrated User Service);

[0129] NMT (Nordic Mobile Telephony);

[0130] PCS (Personal Communications Services);

[0131] PDA (Personal Data Assistant, e.g., PALM and PALM-type “computingplatforms” and/or “connected organizers”);

[0132] PDC (Personal Digital Cellular);

[0133] Signaling System 7 (a telecommunications protocol defined by theInternational Telecommunication Union—ITU—as a way to offload PSTN datatraffic congestion onto a wireless or wireline digital broadbandnetwork);

[0134] SIM (Subscriber Identity Module—smart cards that fit into GSMhandsets, holding information on the phone subscriber and GSM encryptionkeys for security SIM cards that allow GSM subscribers to roam in otherGSM operator networks);

[0135] SIM Toolkit (a GSM standard adopted in 1996 for programming a SIMcard with applications—the SIM toolkit allows operators to offer newservices to the handset);

[0136] SMS (Short Message Service, or the transmission of short textmessages to and from a mobile phone, fax machine and/or IPaddress—messages must be no longer than 160 alpha-numeric characters andcontain no images or graphics);

[0137] SMSC (Short Message Service Center—used in conjunction with SMSto receive short messages);

[0138] TACS (Total Access Communication System);

[0139] TDMA (IS-136 specification for advanced digital wirelessservices);

[0140] 3G (Third Generation of digital wireless technology, promising tobring data speeds of between 64,000 bits per second to 2 megabits persecond—this next generation of networks will generally allow downloadingof video, high quality music and other multimedia—the phones andnetworks also promise to offer cellular phone customers worldwideroaming capabilities because all 3G handsets are expected to contain auniversal SIM);

[0141] UMTS (Universal Mobile Telecommunications System or ThirdGeneration (3G) mobile technology capable of delivering broadbandinformation at speeds up to 2 Mbit s/sec, and in addition to voice anddata, delivering audio and video to wireless devices anywhere in theworld through fixed, wireless and satellite systems);

[0142] WAP (Wireless Application Protocol);

[0143] WCDMA (Wideband Code Division Multiple Access), and

[0144] WCDMA (Wideband Code Division Multiple Access);

[0145] In the present invention, it is preferred that communicationsystem 120 offer a combination of all-digital transparent voice, data,fax and paging services, and that system 120 further provideinteroperability between mobile satellite and cellular networks. It isalso preferred in the present invention that communication system 120permit patients to use mobile phones that are compatible with satellitesystems in any country as well as across a plurality of geographicregions, thereby creating roaming capabilities between differentsystems' regional footprints. In one such embodiment of the presentinvention, mobile telephone 110 may be, for example, a Motorola P7389tri-band mobile telephone or similar device, or include a universal SIM,WAP or other card, chip or code designed to allow patient 5 or healthcare provider 136 worldwide roaming privileges.

[0146] Smart features or cards may be incorporated into mobile phone 110to offer increased security for Internet, international and othertransactions or communications. Moreover, mobile phone 110 may be a“dual-slot” phone having a second slot or connector into which patient 5or health care provider 136 can insert a chip-based card or module formedical service payments, applications, programming, controlling, and/orassisting in controlling the operation of mobile phone 110 and/orcommunications module 100. Mobile phone 110 may also be configured toaccept PCM/CIA cards specially configured to fulfill the role ofcommunication module 100 of the present invention. Alternatively, mobilephone 110 and/or communication module 100 may receive medical servicepayment, application programming, controlling and/or other informationor data by wireless means (e.g., BLUETOOTH technology, infrared signals,optical signals, etc.) from a chip-based card, module or sensor locatedin relatively close proximity to communication module 100 and/or mobiletelephone 110 and in the possession of patient 5 and/or health careprovider 136 or located in sufficiently close proximity to patient 5 orremote health are provider 136 so as to permit reliable communication.Mobile phone 110 may also be an off-the-shelf or specially configuredphone having a plurality sensing electrodes disposed on its backside forsensing ECGs. See for example, the VITAPHONE product manufactured byvitaphone GmbH of Altrip, Germany, which product may be modifiedadvantageously in accordance with several embodiments of the presentinvention upon reading the present disclosure and reviewing the drawingshereof.

[0147] In still another embodiment of the present invention, achip-based card or module capable of effecting telemetric communicationsbetween IMD 10 and mobile phone 110 is configured for insertion into asecond slot of a dual-slot phone, thereby eliminating the need to modifythe housing or other portions of an off-the-shelf mobile phone 110 foruse in the system of the present invention while also preserving thefirst slot of the mobile phone for other applications.

[0148] It is also preferred in the present invention that at leastportions of communication module 100, mobile phone 110, communicationsystem 120 and remote system 130 be capable of communicating inaccordance with the Transmission Control Protocol/Internet Protocol(TCP/IP), the suite of communications protocols used to connect hosts onthe Internet. TCP/IP itself uses several protocols, the two main onesbeing TCP and IP. TCP/IP is built into the UNIX and other operatingsystems and is used by the Internet, making it the de facto standard fortransmitting data over networks. Even network operating systems thathave their own protocols, such as Netware, also support TCP/IP.Communication module 100 and mobile telephone 110 may also be capable ofaccessing the Internet using any one or more of the dial-up IntegratedServices Digital Network (ISDN) direct line, dial-up Euro-ISDN directline, dial-up ADSL direct line, and conventional dial-up (i.e., modemvia phone lines) standards, as well as by through network connections.

[0149] The mobile telephone of the present invention is not limited toembodiments capable of receiving or transmitting voice or datainformation only, but includes within its scope mobile telephones havingweb-browsing, e-mail, data storage, fax, 7 and data uploading and/ordownloading capabilities. The mobile telephone of the present inventionalso includes within its scope “smart” mobile telephones that work asboth mobile phones and handheld computers, mobile telephones havingremovable SIM or other cards.

[0150] The Wireless Application Protocol (WAP) finds useful applicationin some embodiments of communication module 100, mobile telephone 110,communication system 120, and remote system 130 of the present inventionowing to its secure specification that permits patient 5 or remotehealth care provider 136 (such as physician 135) to access informationinstantly via communication module 100 and mobile telephone 110. WAPsupports most wireless networks, including CDPD, CDMA, GSM, PDC, PHS,TDMA, FLEX, ReFLEX, iDEN, TETRA, DECT, DataTAC, and Mobitex. WAP issupported by virtually all operating systems, including PalmOS, EPOC,Windows CE, FLEXOS, OS/9, and JavaOS and perhaps SYMBIAN. WAP employedin conjunction with 3G data transmission is viewed as being aparticularly efficacious component in some embodiments of the presentinvention.

[0151] WAP is also particularly suitable for use in connection someembodiments of the present invention because it can accommodate the lowmemory constraints of handheld devices and the low-bandwidth constraintsof a wireless-handheld network. Although WAP supports HTML and XML, theWML language (an XML application) is specifically devised for smallscreens and one-hand navigation without a keyboard. WML is scalable fromtwo-line text displays up through graphic screens found on items such assmart phones and communicators. WAP also supports WMLScript. It issimilar to JavaScript, but makes minimal demands on memory and CPU powerbecause it does not contain many of the unnecessary functions found inother scripting languages.

[0152] According to one embodiment of the present invention, an operatoror a computer located at remote system 130 initiates remote contact withcommunication module 100. As discussed above, communication module 100is capable of down-linking to and uplinking from IMD 10 via telemetrymodule 101 and antenna or coil 56 and RF transceiver circuit 78 toenable the exchange of data and information between IMD 10 and module100. For example, an operator or a clinician located at remote computer130 may initiate downlinking to communication module 100 to perform aroutine or a scheduled evaluation of the performance of IMD 10 orcommunication module 100. Such downlinking may also be initiated byremote computer 130 according to a pre-programmed or predeterminedschedule, or in accordance with a prescription previously issued by aphysician.

[0153] Alternatively, uplinking of information or data contained in IMD10 may be initiated automatically by IMD 10 or manually by patient 5 toremote computer 130 in response to a detected physiologic event (e.g.,cardiac arrhythmia, cardiac tachycardia, syncope, cardiac fibrillation,vital signs of patient 5 being outside normal ranges, etc.) or an IMDperformance-related event (e.g., low battery, lead failure, excessiveinput impedance, etc.) via communication module 100 and mobile telephone110.

[0154] Examples of data or information that may be uplinked tocommunication module 100 from IMD 10 include, but are in no way limitedto, blood pressure data, electrogram data, electrocardiogram data, pHdata, oxygen saturation data, oxygen concentration data, QT intervaldata, activity level data, accelerometer or piezoelectric sensor data,minute ventilation data, transthoracic impedance data, heart rate data,heart rate variability data, ST elevation data, T-wave alternans data,ICD or PCD charging current status, current battery state of charge,drug pump reservoir level status, drug pump reservoir filling status,catheter occlusion data, IMD prescription table, software applicationversions installed in the IMD, data stored in or acquired by MEDTRONICCHRONICLE devices, and so on.

[0155] Such data may be uplinked in real-time from IMD 10 tocommunication module 100. Alternatively, such data may be stored in amemory or storage device disposed within IMD 10 for uplink according toa predetermined schedule stored in IMD 10, upon sensing of a thresholdphysiologic or IMD performance event, or when interrogated bycommunication module 100.

[0156] Communication module 100 may also acquire such data orinformation from IMD 10 according to a predetermined schedule stored ina memory of communication module 100, and subsequently store such datain memory/storage module 105 until communication module 100 isinterrogated by remote computer system 130 and an instruction isreceived to uplink the information or data to remote system 130.Alternatively, communication module 100 may acquire the information whenprompted to do so by patient 5 or by remote computer system 130.

[0157] In another embodiment of the present invention, a Personal DataAssistant (PDA) or similar device is employed in place of, in additionto or as part of mobile telephone 110. Combined mobile telephone and PDAdevices are specifically contemplated for use in conjunction with thedevices, systems and methods of the present invention. Examples of suchcombined mobile telephones and PDAs include, but are not limited to, theNOKIA Model 9210 device, the MATSUSHITA DILIP MISTRY device, and theCOMPAQ iPAQ device. Communication module 100 is linked wirelessly or viaa physical connection to the PDA, which in turn is capable ofcommunicating through communication system 120 with remote system 130and/or remote health care provider 136. The PDA may communicate with andthrough communication system 120 via wireless means such as mobiletelephonic means, RF means, ultrasonic means, infrared means or opticalmeans, or may communicate with and through communication system 120 viatraditional telephone wire means.

[0158] For example, the PDA or mobile telephone of the present inventioncan be configured to receive and transmit data by infra-red means tocommunication system 120 and/or to communication module 110 located onor near patient 5. As patient 5 roams about his home or ventures toother locations such as suitably equipped hotels, hospitals,communities, automobiles or aircraft the PDA remains capable ofreceiving or transmitting information to or from, for example, infraredsensors or other data communication ports (e.g., BLUETOOTH ports)connected to or forming part of communication system 120, and located inthe walls, fixtures or other portions of the environment through whichpatient 5 is moving or located. Of course, the PDA also remains capableof communicating with communication module 100 (which in turn cancommunicate with IMD 10) so that data may ultimately be exchangedbetween remote system 130 and IMD 10.

[0159] PDA 110 may also be configured to automatically communicate withIMD 10 or communication system 120, or can be configured to do so uponthe prompting or initiation of patient 5, remote health care provider136, IMD 10 or remote system 130. In such a manner, it is contemplatedin the present invention that IMD 10, communication module 100 and/ormobile telephone or PDA 110 can remain in continuous, relativelycontinuous or at least intermittent communication with remote system 130and/or health care provider 136 even as patient 5 drives an automobile,goes to work, travels through airports or on aircraft, walks throughbuildings and so on.

[0160] PDA 110 can also Mobile phone 110 may also be configured toaccept PCM/CIA cards specially configured to fulfill the role ofcommunication module 100 of the present invention. Alternatively, PDA110 and/or communication module 100 may receive medical service payment,application programming, controlling and/or other information or data bywireless means (e.g., BLUETOOTH technology, infrared signals, opticalsignals, etc.) from a chip-based card, module or sensor located inrelatively close proximity to communication module 100 and/or PDA 110and in the possession of patient 5 and/or health care provider 136 orlocated in sufficiently close proximity to patient 5 or remote healthare provider 136 so as to permit reliable communication. PDA 110 mayalso be an off-the-shelf or specially configured PDA having a pluralitysensing electrodes disposed on its backside for sensing ECGs or othersignals.

[0161] It is further contemplated in the present invention thatcommunication module 100/110 comprise a hand-held mobile telephonehaving WAP or BLUETOOTH capabilities, or a hand-held mobile telephonehaving keyboard and/or Liquid Crystal Display (LCD) means for enteringor responding to screen displays or information. See, for example, theR380 handset manufactured by Ericcson of Sweden. Monochrome and colorLCD and other types of displays are also contemplated for use with themobile telephone or PDA of the present invention. It is furthercontemplated in the present invention that an off-the-shelf mobiletelephone, or combined PDA and mobile telephone having a removablefaceplate, where the original faceplate is removed from the phone or PDAand replaced with a custom faceplate where

[0162] Keyboardless mobile telephones 110, PDAs 110, or combined mobiletelephones/PDAs 110 are also contemplated in the present invention,where patient 5 taps on the display to bring up or enter information ina manner similar to that now employed in, for example, PALM-, HANDSPRINGVISOR- or SONY CLIE-brand PDAs.

[0163] It is also contemplated that patient 5 interact withcommunication module 100/110, remote system 130 and/or remote healthcare provider 136 by tapping on screen icons displayed on a screenincorporated into communication module 100/110. The icons could be, forexample, an ambulance icon indicating the need for emergency care, aprinter icon indicating that the patient desires to have module 100/110print out or display a report on the patient's health, a physician iconindicating that the patient wishes to communicate with his remote healthcare provider, and so on. Incorporated by reference herein, in itsentirety, is the “Handbook for the Palm V Organizer”, P/N: 405-1139,A/N: 423-1138 published by Palm Computing, Inc. of Santa Clara, Calif.After reading the present disclosure and reviewing the drawings thereofit will become clear that many applications of PDAs can be envisaged orimplemented in conjunction with or as part of the various embodiments ofthe communication systems and methods of the present invention.

[0164] In still other embodiments of the present invention,communication module 100 may be incorporated into or onto, or form apart of, a device such as a patch or module adhered or otherwise securedto or located near the skin or clothing of patient 5, or subcutaneouslybeneath the skin of patient 5, the device being located on, near or inthe patient in such a position as to reliable permit telemetric or othercommunication with IMD 10, as well as with mobile telephone or PDA 110.Mobile telephone or PDA 110 may further be incorporated into such adevice, volume, form factor and weight permitting. See, for example,U.S. Pat. No. 5,634,468 to Platt et al. which describes devices that maybe readily adapted in conformance with the immediately foregoingembodiments of the present invention. Such a device or patch may also beconfigured to hold and deliver beneficial agents to patient 5 inresponse to receiving an appropriate signal or input from remote healthcare provider 136, remote system 130, communication module 100 and/ormobile telephone or PDA 110, or IMD 10. That is, such a device may be,by way of example only, an implantable drug pump or dispenser, anon-implantable drug pump or dispenser, a subcutaneous drug pump ordispenser, a patch capable of transmitting or delivering a beneficialagent to patient 5 electrically, mechanically, transdermally,iontophoretically, electrophoretically or otherwise. See, for example,the devices and methods disclosed in U.S. Pat. Nos. 6,126,642;6,126,637; 6,105,442; 6,095,491; 6,090,071; 6,086,561; 6,086,560;6,045,533; 6,063,059; 6,030,363; 6,027,472; 6,010,482; 6,007,518;5,993,425; 5,993,421; 5,980,489; 5,962,794; 5,961,492; 5,957,891;5,925,017; 5,921,962; 5,906,703; 5,906,592; 5,885,250; 5,876,377;5,858,005; 5,873,857; 5,840,071; 5,830,187; 5,807,335; 5,807,323;5,779,676; 5,776,103; 5,743,879; 5,741,242; 5,735,818; 5,720,729;5,716,343; 5,700,244; 5,693,019; 5,693,018; 5,656,032; 5,649,910;5,569,236; 5,545,139; 5,531,683; 5,514,090; 5,484,415; 5,484,410;5,468,226; 5,433,709; 5,419,771; 5,411,480; 5,385,546; 5,385,545;5,374,256; 5,372,578; 5,354,278; 5,336,188; 5,336,180; 5,334,197;5,330,426; 5,328,464; 5,314,405; 5,279,558; 5,267,957; 5,263,940;5,236,418; 5,205,820; 5,122,116; and 5,019,047, all assigned to ScienceInc. of Bloomington, Minn., at least some of which devices and methodsmay be modified advantageously in accordance with the teachings of thepresent invention and the patch, module or other such device describedhereinabove.

[0165] Referring now to FIG. 8, communication module 100 is illustratedas being capable of communicating with one or a plurality of IMDs 10,10′ or 10″. As discussed above, those IMDs are most preferably capableof communicating wirelessly or by other means (such as throughinterconnecting leads or electrical conductors) with one another. See,for example, U.S. Pat. No. 4,886,064 to Strandberg which describesdevices that may be readily adapted in conformance with the immediatelyforegoing embodiments of the present invention. FIG. 8 also shows thatin some embodiments of the present invention remote system 130 maycomprise a remote expert or other type of system and/or data center 131,and may further comprise data resource system 112.

[0166] We refer now to FIGS. 9A and 9B, where flow charts for twomethods of the present invention relating to patient-initiatedcommunication between IMD 10 and/or communication module 100/mobiletelephone or PDA 110 and various components of remote system 130 viacommunication system 120 are illustrated. It is contemplated in FIGS. 9Aand 9B that a PDA, PDA-capable mobile telephone or PDA-type device beoptionally employed, either as a replacement for mobile telephone 110,in addition to mobile telephone 110 or as part of mobile telephone 110.

[0167] In FIG. 9A, patient 5 at step 201 determines or desires thatmedical attention should be provided or is required. Such adetermination or desire may be based on physiological events whichpatient 5 or others in his company sense, or may be based merely uponthe patient's feeling or desire that his health status or theperformance status of his IMD 10 ought to be checked. At step 203,patient 5 initiates upload of data from IMD 10 to communication module100 by pressing an appropriate button or portion of communication module100, or issuing an appropriate voice command to same. IMD 10 andcommunication module 100 then communicate with one another and the dataare uploaded. Alternatively, step 203 may be skipped if the desired datahave already been uploaded by communication module 100 and are nowstored in memory/storage medium 105.

[0168] Next, at step 207 the data are transferred from communicationmodule to mobile telephone or PDA 110, and thence on to remote system130 via communication system 120. At step 209, remote health careprovider 136, remote computer system 131 and/or 131′, and/or a remoteexpert computer system evaluate, review and analyze the data. In step211, diagnosis of the patient's condition (and/or that of IMD 10,communication module 100, and/or mobile telephone or PDA 110) is made byone or more of remote health care provider 136, remote computer system131 and/or 131′, and/or a remote expert computer system.

[0169] At step 213, any one or more of remote health care provider 136,remote computer system 131 and/or 131′, and/or a remote expert computersystem determines, on the basis of the analysis, whether patient 5,communication module 100, mobile telephone or PDA 110 and/or IMD 10require further attention, correction or intervention. If the analysisreveals that patient 5, communication module 100, mobile telephone orPDA 110 and/or IMD 10 is functioning normally within acceptable limits,patient 5 may be so notified via communication system 120, mobile phone110 and a visual display or audio signal emitted by communication module100 (or mobile phone or PDA 110). If, on the other hand, the analysisreveals that a problem exists in respect of any one or more of IMD 10,communication module 100, mobile telephone or PDA 110, and/or patient 5,then remote system 130 and/or health care provider 136 determines anappropriate remedial response to the problem, such as changing theoperating parameters of IMD 10, communication module 100 and/or mobiletelephone or PDA 110, delivering a therapy to the patient (e.g., apacing, cardioverting or defibrillating therapy, or administration of adrug or other beneficial agent to patient 5), or instructing patient 5by audio, visual or other means to do something such as lie down, go tothe hospital, call an ambulance, take a medication, or push a button.

[0170] The remedial response or therapy determined in step 217 is nextexecuted at step 219 by remote health care provider 136 or remote system130 and relayed at step 221 via communication system 120 tocommunication module 100 and/or IMD 10 via mobile phone or PDA 110.After the remedial response or therapy has been delivered, at step 225communication module and/or mobile telephone 110 may send a confirmatorymessage to remote system 130 and/or remote care giver 136 indicatingthat the remedial response or therapy has been delivered to patient 5and/or IMD 10.

[0171] Communication module 100 and/or mobile telephone or PDA 110 mayalso store data concerning the patient-initiated chain of eventsdescribed above so that the data may be later retrieved, analyzed,and/or a future therapy determined at least partially on the basis ofsuch data. Such data may also be stored by remote data system 130 forlater retrieval, analysis and/or future therapy determination.

[0172] It is to be noted that all steps illustrated in FIG. 9A need notbe carried out to fall within the scope of the present invention.Indeed, it is contemplated in the present invention that some stepsillustrated in FIG. 9A may be eliminated or not carried out, that stepsillustrated in FIG. 9A may be carried out in an order different fromthat shown in FIG. 9A, that steps other than those explicitlyillustrated in the Figures may be inserted, and that steps illustratedin different Figures set forth herein (i.e., FIGS. 9B, 9C, 10A, 10B,11A, 11B, 12 a, 12B, 12C, 13A and 13B) maybe combined in variouscombinations and permutations, and nevertheless fall within the scope ofcertain embodiments of the present invention. The same considerationshold true for all flow charts and methods illustrated in the drawingshereof and described herein.

[0173] In FIG. 9B, some of the same steps shown in FIG. 9A are executed.Invoice generation steps 229 may be automatically generated inconjunction with or in response to one or more of steps 201, 207, 213A,213B, 217, 225 or 227 being carried out. The invoices so generated maybe electronically transmitted to appropriate locations for furtherprocessing and billing. The amounts of the invoices so generated maydepend, for example, on the number, type and/or frequency of servicesprovided to patient, the type or identification indicia stored incommunication module 100 or IMD 10, and other factors.

[0174]FIG. 9C shows another method of the present invention related tothe methods illustrated in FIGS. 9A and 9B. In FIG. 9C patient 5determines that medical attention is required or desirable. Steps 203and 205 are equivalent to those described above in respect of FIGS. 9Aand 9B. At step 206 a, uploaded data from IMD 10 or data previouslyuploaded from IMD 10 stored in communication module 100 and/or mobiletelephone or PDA 110 are compared to pre-programmed or stored dataand/or data ranges to help establish whether the uploaded data fallwithin a safe range.

[0175] If the comparison of data reveals that the uploaded data fallinto a safe range, then patient 5 is so alerted at step 227. If thecomparison of data reveals that the uploaded data do not fall within thesafe range represented by the pre-programmed or stored data, then steps213, 217 and 219 illustrated in FIGS. 9A and/or 9B are carried out.Patient 5 or patient 5's health care provider or insurer may be billedfor the request for medical attention made at step 201 or any or all ofsteps 229.

[0176] When a diagnostic assessment, remedial response or therapy isexecuted and relayed to IMD 10, communication module 100 and/or mobiletelephone or PDA 110, charges may be billed to patient 5 or patient 5'shealth care provider or insurer at a fixed rate or at a rateproportional to the amount of time required to relay or execute theassessment, response or therapy, or at a rate which depends upon theparticular type of information, assessment, remedial response or therapybeing delivered to patient 5.

[0177] Other steps shown in FIG. 9C may also be carried out, such ashaving prescription drugs mailed to patient 5 and billed to an insurancecompany or reimbursement authority at steps 217/231 in response toreceiving appropriate and timely authorization from patient 5, remotehealth care provider 136 and/or an insurer, placing patient 5 onperiodic surveillance for a fee and/or requesting that patient 5authorize charges for such surveillance at steps 217/231, determiningpatient 5 should be taken to the emergency unit of a hospital, orderingan ambulance for patient 5 and billing charges for the ambulance serviceto the appropriate entity at steps 217/229, and determining at step 217that the operating parameters of IMD 10, communication module 100 and/ormobile phone or PDA 110 need to or should be updated or changed,followed by requesting at step 231 that patient 5, health care provider136 or an insurer confirm acceptance of charges for such parameterupdates or changes before or at the same time as they are implemented.

[0178] In other methods of the present invention, it is contemplatedthat pre-paid telephone or other magnetic cards be used in conjunctionwith communication module 100 and/or mobile telephone or PDA 110 as ameans of authorizing the provision of services, medications,prescriptions and information. Such pre-paid cards could be employed inconjunction with telephone service providers and their billing andinvoicing systems. Referring briefly to FIGS. 6A through 6C, and by wayof example only, when telephone/PDA 110 establishes communication viacommunication system 120, the telephone service provider involved incarrying out at least some of the functions of communication system 120can keep track of and calculate charges made using pre-paid cards by aparticular patient 5. The amount of charges billed against a pre-paidcard could be made dependent on the complexity of the procedures andservices which are initiated by patient 5, IMD 10 and/or communicationmodule 100/mobile telephone or PDA 110. For example, a routine check ofthe battery state of charge of IMD 10 could cost a low number ofmagnetic impulses stored on the pre-paid card, while an instruction todeliver a tachycardia intervention originating from remote system 130could cost a high number of magnetic impulses stored on the pre-paidcard. Additionally, the communication system of the present inventioncan be configured to store and tally bonus points for patient 5, wherethe number of bonus points stored for patient 5 depends, for example, onthe number of transactions patient 5 has engaged in or initiated usingthe methods, systems or devices of the present invention. For example,if a pharmaceutical company conducting a clinical trial or studyinvolving IMD 10 and/or a prescription drug manufactured by the companythat is being used in the study wishes to purchase data from patient 5or patient 5's IMD 10, communication module 100 and/or mobile telephoneor PDA 110, and patient 5 authorizes such purchase, patient 5's pre-paidcard could be credited with a number of extra magnetic pulses or extrabonus points could be stored in his behalf, by, for example, a telephoneservice provider. At some point patient 5 can receive a cash or otherreimbursement according to the total number of bonus points he hasaccumulated.

[0179] It is important to note that the billing inquiry, acceptance,authorization and confirmation steps illustrated in the various Figureshereof or described herein may include communications with anddeterminations made by an insurer having access to at least portions ofthe various communication networks described herein. Additionally, it isimportant to point out that it is contemplated in the present inventionthat a telephone service provider can be involved in the automatedinvoicing and billing methods of the present invention, and that patient5 and/or remote system 130 and/or remote health care provider 136 beinvolved or be permitted to be involved in the service requestinitiation, remedial action determination and execution, and billinginquiry, acceptance, authorization and confirmation steps illustrated inthe various Figures hereof and described herein.

[0180] Thus, it will now become apparent that one important aspect ofthe various embodiments of the present invention is automated andstreamlined billing and invoicing methods that increase patientempowerment, lower health care costs and result in the delivery of morecustomized and timely therapies and remedial actions to patient 5. Forexample, if in any of FIGS. 9A through 9C patient 5 caries out step 201by, e.g., pressing an appropriate button, a screen or display oncommunication module 100 and/or mobile phone or PDA 110, one or moremessages could be displayed to patient 5 such as: “Your heart rate isOK”, “You are not in atrial fibrillation”, “Call the hospitalImmediately”, or “Go to Hospital”.

[0181] Inquiries made by patient 5, communication module 100, IMD 10,mobile phone or PDA 110, remote health care provider 136 or remotesystem 130, and the invoices generated in response to those inquiriesbeing made, may be separated into three main categories:

[0182] (i) patient visible inquiries, where the patient confirms theinquiry he wishes to make, an invoice is generated automatically, andthe invoice is logged;

[0183] (ii) patient relayed inquiries, where the patient is requested tocarry out an action such as taking a medication or confirming that hewishes to receive a therapy before an invoice is generated automaticallyand the invoice is logged;

[0184] (iii) patient invisible inquiries, where IMD 10, communicationmodule 100, mobile phone or PDA 110, remote system 130 or remote healthcare provider 136 initiates communication for patient monitoring,clinical study monitoring, therapeutic, clinical outcome study or otherpurposes to thereby minimize unnecessary patient-physician orpatient-hospital interaction.

[0185] Phone or PDA 110 and/or communication module 100 could beprovided at no up-front cost to patient 5. Once patient 5 activates orrequests a service using phone or PDA 110 and/or communication module100, the bills for services incurred subsequently or simultaneouslycould be charged through a telephone company operating in a businessalliance with remote health care provider 136.

[0186] Such automated billing methods and health care delivery serviceshave the potential to reduce overall health care costs and improve thetimely and efficient delivery of therapies and remedial responses topatient 5 because remote health care provider 136 would be monitoringthe health status of patient 5 and/or delivering therapies to patient 5without the involvement of expensive institutions such as hospitals orclinics. Accordingly, the methods and procedures of some embodiments ofthe present invention could deduces the number of unnecessary emergencyroom visits or physician consultations made by patient 5.

[0187] Automated invoicing may also be carried out at the opposite endof the system of the present invention, such as at remote health areprovider 136 or physician 135, such that when remote health careprovider 136 and/or physician 135 requests delivery of information or atherapy to patient 5, an invoice is automatically generated and isbilled, for example, through a telephone company or to an insurancecompany or reimbursement authority.

[0188] Review and authorization of government reimbursements forservices charges incurred as a result of using the various systems andmethods of the present invention could also be automated. Reimbursementcosts, patient identities and other data associated with reimbursementcould be tracked and centralized very efficiently and easily using themethods of the present invention. IMD 10, mobile phone or PDA 110 an/orcommunication module 100 could have a patient identity code storedtherein for transmittal to remote system 130. Such a code could beemployed at remote system 130 or elsewhere to verify the identity ofpatient 5 or the type or model of IMD 10, communication module 100and/or mobile phone or PDA 110, and receipt of such a code could beemployed as a precondition to receiving information, remedial action ora therapy from remote system 130.

[0189] In other billing methods of the present invention, a serverlocated at remote health care provider 136 contacts patient 5 via mobilephone or PDA 110 and inquires whether patient 5 would like to receive atherapy, remedial action or information from remote system 30 and/orhealth care provider 136 or another source, the provision of which willresult in patient 5 or an insurance company being billed. Patient 5 mustconfirm he wishes to receive such information, remedial action ortherapy before delivery of same. Insurance company or reimbursementauthority authorization could be included in such a method as aprerequisite to receiving the information, remedial action or therapy.

[0190] In one method of the present invention, remote system or server130 automatically contacts patient 5 according to a predeterminedschedule, upon receiving instructions to do so from another source(e.g., a physician, or a data mining project which results in detectinga trend or symptom characterizing patient 5 and other like individuals),or in response to receiving information relayed to remote system 130 asa result of IMD 10 and/or communication module 100/mobile phone or 110initiating communication with remote system 130 in response to detectinga condition in patient 5 or his environs that requires monitoring ofpatient 5, analysis of data from patient 5 or the execution of remedialaction.

[0191] In another method of the present invention, patient 5 or herinsurance company leases or rents module 100 and/or mobile phone or PDA110 on a daily, weekly, monthly, quarterly, annual or other basis. Insuch a method, module 100 and/or mobile phone or PDA 110 are leased orrented for the period of time required to monitor IMD 10 implanted inpatient 5, deliver remedial action or therapy to patient 5 via IMD 10and/or another medical device, or acquire data from IMD 10 and/orcommunication module 100/mobile phone or PDA 110. For example, patient 5may be a terminally or seriously ill patient who is not expected tosurvive longer than a period of months or weeks, where economicconsiderations or reimbursement policies might otherwise dictate thatone or more of the various systems or methods of the present inventionnot be employed to treat or monitor patient 5 because of prohibitivelyhigh costs. Once patient 5 becomes well again or dies, module 100 and/ormobile phone or PDA 110 may be used to treat or monitor other patients,thereby lowering patient, insurance, reimbursement, hospital, physiciancosts while improving the quality and type of care administered topatient 5.

[0192] In another method of the present invention, IMD 10 may beprovided to and implanted within patient 5 and be capable of effectingrather broad features and functionalities that may be selectively andremotely activated or de-activated under the control of remote system130 communicating with IMD 10 via communication system 120 and mobilephone or PDA 110 and/or communication module 100. In such a method, itis contemplated that perhaps only certain of the available features ofIMD 10 may be required to treat and/or monitor patient 5, and that onlycertain or all of those features may be selected initially by aphysician. Subsequently, and most preferably after data have beenacquired by IMD 10 and transferred therefrom to remote system 130 usingthe communication system of the present invention or in response toinformation provided or inquiries made by patient 5, physician 135,remote health care provider 136 and/or remote system 130, certain of thefeatures or functionalities possessed by IMD 10 may be terminated oractivated.

[0193] For example, it may be determined that IMD 10 has not beenoptimally programmed for a particular patient 5 once sufficient datahave been acquired and evaluated remotely at system 130. New IMD orupdated patient specific operating parameters can then be downloaded toIMD 10, and/or IMD functionalities or features can be enabled ordisabled in IMD 10. According to such a method, IMD 10 and/orcommunication module 100/mobile phone or PDA 110 may be providedinitially to patient 5 with a minimum number of features orfunctionalities, and therefore sold at the lowest possible initial cost.After an initial trial operation period during which data are collectedfrom IMD 10 and/or communication module 100/mobile phone or PDA 110, orduring which feedback is elicited from patient 5 and/or physician 135,it may be desirable to update or change the functionality of IMD 10 soas to offer more advanced therapy or monitoring capabilities to patient5 via IMD 10. Once such updates or changes are implemented in IMD 10 anew invoice is generated reflecting the incremental cost of adding thenew capabilities or features to IMD 10 and/or communication module100/mobile phone or PDA 110.

[0194] In accordance with such methods of the present invention,patients 5 may in some cases be able to leave the hospital earlier thanmight otherwise be possible because of the built-in remote monitoringand adaptability capabilities of the system of the present invention.Additionally, the invoices generated in accordance with the variousmethods of the present invention could result in smaller payments beingmade over longer periods of time, thereby further lowering overallhealth care costs while at the same time improving the quality and typeof care provided to patients 5.

[0195] It will now become clear that an almost infinite number ofcombinations and permutations of the various steps of the invoicingmethods of the present invention may be conceived of and implemented inaccordance with the teachings of the present invention. For example, ator after step 217 in any of FIGS. 9A, 9B and 9C a report may begenerated at remote system 130 or at communication module 100 and/ormobile telephone or PDA 110. Or remote system 130 or remote health careprovider 136 may, in response to receiving a request for medicalattention from patient 5, IMD 10 and/or communication module 100/mobiletelephone or PDA 110, contact a physician or specialist indicated in adatabase of remote system 130 as being patient 5's emergency contact torequest that the physician or specialist review data or reports providedby the system of the present invention and subsequently adjust theoperating parameters of IMD 10. Or IMD 10 may be re-programmed with newsoftware or algorithms in response to review and analysis of informationobtained remotely from IMD 10. Or invoices, reports, confirmations ofbilling, confirmations of therapy delivery, and so on generated by thevarious methods of the present invention may be automaticallytransmitted in a pre-programmed or predetermined manner to insurancecompanies, reimbursement authorities, hospitals, physicians, patients,health care professionals or other persons or institutions via fax,e-mail, postal service, express mail, voice mail, SMA or other knowncommunication means.

[0196] The methods and devices of the present invention could alsopermit the process of obtaining patient consents to the release ofmedical information to be streamlined. For example, patient 5 could beinterrogated on an as-required basis via mobile phone or PDA 110 toprovide confirmation that the data or information that has beenacquired, is being acquired, or will be acquired from or relating to himmay be released to certain entities or personnel, such as insurancecompanies, clinical study managers, physicians, nurses, hospitals andgovernmental or academic institutions. A log of the patient's responsesto such inquiries could be maintained in the memory or storage ofcommunication module 100 or remote system 130.

[0197] As mentioned briefly above, the various methods and devices ofthe present invention may also be configured and adapted to moreefficiently and cost-effectively administer clinical monitoring studiesand clinical outcome studies. In accordance with one embodiment of thepresent invention, IMDs implanted in patients 5 and/or correspondingcommunication modules 100 or mobile phones or PDAs 110, where patients 5are participating in clinical outcome studies and/or clinical monitoringstudies, are interrogated for data required or desired for purposes ofcompleting such studies. Devices 10, 100 and/or 110 are remotelyinterrogated using remote system 130 and communication system 120.Patients 5 are remotely interrogated for the required data on anas-required basis, or according to a predetermined schedule, eitherautomatically or under the direct or indirect control of remote healthcare provider 136. According to this method of the present invention,there is no need for patients having to go to clinics or hospitals tohave data uploaded from their IMDs so that data required for the studiesmay be acquired. Accordingly, patient, clinical study and overall healthcare costs are reduced, while the rate at which such studies may becompleted, and the scope, amount and types of clinical data which may beacquired using such methods, are increased.

[0198] We refer now to FIGS. 10A and 10B, where flow charts for twomethods of the present invention relating to device-initiatedcommunication between IMD 10 and/or communication module 100/mobiletelephone or PDA 110 and various components of remote system 130 viacommunication system 120 are illustrated. It is contemplated in FIGS.10A and 10B that a PDA, PDA-capable mobile telephone or PDA-type devicebe optionally employed, either as a replacement for mobile telephone110, in addition to mobile telephone 110 or as part of mobile telephone110.

[0199] In FIG. 10A, IMD 10 and/or communication module 100 and/or mobiletelephone or PDA 110 at step 301 senses a threshold event, apredetermined time arrives, or makes a determination that medicalattention or information should be provided or is required. Such athreshold sensing event, predetermined time or determination may bebased, for example, on physiological events sensed in patient 5, apredetermined schedule or calculations made by IMD 10 and/orcommunication module and/or mobile telephone or PDA 110 using datasensed or provided by IMD 10.

[0200] At step 303, IMD 10 and/or communication module 100 and/or mobiletelephone or PDA 110 automatically initiates the upload of data from IMD10 to communication module 100 and/or mobile telephone or PDA 110. IMD10 and communication module 100 then communicate with one another andthe data are uploaded. Alternatively, step 303 may be skipped if therequired data have already been uploaded into communication module 100and/or mobile telephone or PDA 110 and are now stored in memory/storagemedium 105.

[0201] Next, at step 307, the data are automatically transferred fromcommunication module 100 to mobile telephone or PDA 110, if required,and thence on to remote system 130 via communication system 120. At step309, remote health care provider 136, remote computer system 131 and/or131′, and/or a remote expert computer system evaluate, review andanalyze the data. In step 311, diagnosis of the patient's condition(and/or that of IMD 10, communication module 100, and/or mobiletelephone or PDA 110) is made by one or more of remote health careprovider 136, remote computer system 131 and/or 131′, and/or a remoteexpert computer system.

[0202] At step 313, any one or more of remote health care provider 136,remote computer system 131 and/or 131′, and/or a remote expert computersystem determines, on the basis of the analysis, whether patient 5,communication module 100, mobile telephone or PDA 110 and/or IMD 10require further attention, correction or intervention. If the analysisreveals that patient 5, communication module 100, mobile telephone orPDA 110 and/or IMD 10 is functioning normally within acceptable limits,IMD 10 and/or communication module 100 and/or mobile telephone or PDA110, or patient 5, may be so notified via communication system 120,mobile phone 110, and a visual display or audio signal may be emitted bycommunication module 100 (or mobile phone or PDA 110).

[0203] If, on the other hand, the analysis reveals that a problem existsin respect of any one or more of IMD 10, communication module 100,mobile telephone or PDA 110, and/or patient 5, then remote system 130and/or health care provider 136 determines an appropriate remedialresponse to the problem, such as changing the operating parameters ofIMD 10, communication module 100 and/or mobile telephone or PDA 110,delivering a therapy to the patient (e.g., a pacing, cardioverting ordefibrillating therapy, or administration of a drug or other beneficialagent to patient 5), or instructing patient 5 by audio, visual or othermeans to do something such as lie down, go to the hospital, call anambulance, take a medication, or push a button.

[0204] The remedial response or therapy determined in step 317 is nextexecuted at step 319 by remote health care provider 136 or remote system130 and relayed at step 321 via communication system 120 tocommunication module 100 and/or IMD 10 via mobile phone or PDA 110.After the remedial response or therapy has been delivered, at step 325communication module and/or mobile telephone or PDA 110 may send aconfirmatory message to remote system 130 and/or remote care giver 136indicating that the remedial response or therapy has been delivered topatient 5 and/or IMD 10.

[0205] Communication module 100 and/or mobile telephone or PDA 110 mayalso store data concerning the patient-initiated chain of eventsdescribed above so that the data may be later retrieved, analyzed,and/or a future therapy determined at least partially on the basis ofsuch data. Such data may also be stored by remote data system 130 forlater retrieval, analysis and/or future therapy determination.

[0206] It is to be noted that all steps illustrated in FIG. 10A need notbe carried out to fall within the scope of the present invention.Indeed, it is contemplated in the present invention that some stepsillustrated in FIG. 10A may be eliminated or not carried out, that stepsillustrated in FIG. 10A may be carried out in an order different fromthat shown in FIG. 10A, that steps other than those explicitlyillustrated in the Figures may be inserted, and that steps illustratedin different Figures set forth herein (i.e., FIGS. 9A, 9B, 9C, 10B, 11A,11B, 12 a, 12B, 12C, 13A and 13B) may be combined in variouscombinations and permutations, and nevertheless fall within the scope ofcertain embodiments of the present invention. The same considerationshold true for all flow charts and methods illustrated in the drawingshereof and described herein.

[0207] In FIG. 10B, some of the same steps shown in FIG. 10A areexecuted. Invoice generation steps 229 may be automatically generated inconjunction with or in response to one or more of steps 301, 307, 311,313A, 313B, 317, 325 or 327 being carried out. The invoices so generatedmay be electronically transmitted to appropriate locations for furtherprocessing and billing. The amounts of the invoices so generated maydepend, for example, on the number, type and/or frequency of servicesprovided to patient, the type or identification indicia stored incommunication module 100 or IMD 10, and other factors.

[0208] We refer now to FIGS. 11A and 11B, where flow charts for twomethods of the present invention relating to remote system 130 and/orremote health care provider 136 (which may include or even be limited tophysician 135) initiated communication between IMD 10 and/orcommunication module 100 and/or mobile telephone or PDA 110 and variouscomponents of remote system 130 via mobile telephone or PDA 110 areillustrated. It is contemplated in FIGS. 11A and 11B that a PDA,PDA-capable mobile telephone or PDA-type device be optionally employed,either as a replacement for mobile telephone 110, in addition to mobiletelephone 110 or as part of mobile telephone 110.

[0209] In FIG. 11A, remote system 130 and/or remote health care provider136 determines that medical attention or information should be providedto patient 5 or is required by patient 5. A determination that suchattention or information should be provided may be based on data orinformation previously relayed to remote system 130 or remote healthcare provider 136 by IMD 10 and/or communication module 100 and/ormobile telephone which is subsequently analyzed to determine if aremedial response is required or desirable, information contained in orgenerated by remote system 130 or an outside source of information (suchas patient data monitoring intervals suggested or formulated by themanufacturer of IMD 10), or the action of health care provider 136.

[0210] At step 403, remote system 130 and/or remote health care provider136 initiates upload of data from IMD 10 to communication module 100and/or mobile telephone or PDA 110 via communication system 120. IMD 10and communication module 100 then communicate with one another and thedata are uploaded. Alternatively, step 403 may be skipped if the desireddata have already been uploaded by communication module 100 and/ormobile telephone or PDA 110 and are now stored in memory/storage medium105. Next, at step 407, the data are transferred from communicationmodule to mobile telephone or PDA 110, and thence on to remote system130 via communication system 120. At step 409, remote health careprovider 136, remote computer system 131 and/or 131′, and/or a remoteexpert computer system evaluate, review and analyze the data.

[0211] At step 411, diagnosis of the patient's condition (and/or that ofIMD 10, communication module 100, and/or mobile telephone or PDA 110) ismade by one or more of remote health care provider 136, remote computersystem 131 and/or 131′, and/or a remote expert computer system. At step413, any one or more of remote health care provider 136, remote computersystem 131 and/or 131′, and/or a remote expert computer systemdetermines, on the basis of the analysis, whether patient 5,communication module 100, mobile telephone or PDA 110 and/or IMD 10require further attention, correction or intervention.

[0212] If the analysis reveals that patient 5, communication module 100,mobile telephone or PDA 110 and/or IMD 10 is functioning normally withinacceptable limits, patient 5 may be so notified via communication system120, mobile phone 110 and a visual display or audio signal emitted bycommunication module 100 (or mobile phone or PDA 110).

[0213] If, on the other hand, the analysis reveals that a problem existsin respect of any one or more of IMD 10, communication module 100,mobile telephone or PDA 110, and/or patient 5, then remote system 130and/or health care provider 136 determines an appropriate remedialresponse to the problem, such as changing the operating parameters ofIMD 10, communication module 100 and/or mobile telephone or PDA 110,delivering a therapy to the patient (e.g., a pacing, cardioverting ordefibrillating therapy, or administration of a drug or other beneficialagent to patient 5), or instructing patient 5 by audio, visual or othermeans to do something such as lie down, go to the hospital, call anambulance, take a medication, or push a button.

[0214] The remedial response or therapy determined in step 417 is nextexecuted at step 419 by remote health care provider 136 or remote system130 and relayed at step 421 via communication system 120 tocommunication module 100 and/or IMD 10 via mobile phone or PDA 110.After the remedial response or therapy has been delivered, at step 425communication module and/or mobile telephone 110 may send a confirmatorymessage to remote system 130 and/or remote care giver 136 indicatingthat the remedial response or therapy has been delivered to patient 5and/or IMD 10. Communication module 100 and/or mobile telephone or PDA110 may also store data concerning the patient-initiated chain of eventsdescribed above so that the data may be later retrieved, analyzed,and/or a future therapy determined at least partially on the basis ofsuch data. Such data may also be stored by remote data system 130 forlater retrieval, analysis and/or future therapy determination.

[0215] It is to be noted that all steps illustrated in FIG. 11A need notbe carried out to fall within the scope of the present invention.Indeed, it is contemplated in the present invention that some stepsillustrated in FIG. 11A may be eliminated or not carried out, that stepsillustrated in FIG. 11A may be carried out in an order different fromthat shown in FIG. 11A, that steps other than those explicitlyillustrated in the Figures may be inserted, and that steps illustratedin different Figures set forth herein (i.e., FIGS. 9A, 9B, 9C, 10A, 10B,11B, 12 a, 12B, 12C, 13A and 13B) be combined in various combinationsand permutations, and nevertheless fall within the scope of certainembodiments of the present invention. The same considerations hold truefor all flow charts and methods illustrated in the drawings hereof anddescribed herein.

[0216] In FIG. 11B, some of the same steps shown in FIG. 11A areexecuted. Invoice generation steps 429 may be automatically generated inconjunction with or in response to one or more of steps 401, 407, 413A,413B, 417, 423 or 427 being carried out. The invoices so generated maybe electronically transmitted to appropriate locations for furtherprocessing and billing. The amounts of the invoices so generated maydepend, for example, on the number, type and/or frequency of servicesprovided to patient, the type or identification indicia stored incommunication module 100 or IMD 10, and other factors.

[0217] In the methods illustrated in FIGS. 11A and 11B it is furthercontemplated that IMD 10 be remotely interrogated by remote system orserver 130 that automatically communicates with IMD 10 via communicationmodule 100 and/or mobile telephone or PDA 110, and that data from IMD 10and/or communication module 100 and/or mobile telephone or PDA 110 beretrieved therefrom automatically.

[0218]FIG. 12A shows one embodiment of communication module 100, mobiletelephone or PDA 110, communication system 120, and remote computersystem 130 of the present invention, where remote computer system 130comprises remote expert system 131 and data resource system 112. Here,communication module 100 includes configuration database 114, whichfurther comprises software database 116 and hardware database 118.Patient interface module 115 and management module 122 may also becontained in communication module 100. Those systems preferably formhigh level software systems that may be remotely or otherwise upgradedas the need arises through the action and downlinking of software fromremote computer system 130, or alternatively through on-site softwareupgrading.

[0219] Referring now to FIGS. 12A, 12B and 12C together, remote expertdata center 131 is most preferably a web-based data resources and expertsystem. Accordingly, data resource system 112 is a sub-component ofremote data center 131. Data resource system 112 may comprisecommunication manager management module 124 (which preferably controlsand optimizes bi-directional data communications between mobiletelephone or PDA 110 and communication module 100), programmerconfiguration database 126, released software database 128 and rule setdatabase 133. Those databases and module may be employed to storesoftware upgrades, which in turn may be transmitted to mobile telephoneor PDA 110 and communication module 100 and/or IMD 10 via one or acombination of the various communication channels described above.

[0220] It is preferred that remote system 130 and data resource system112 comprise a high speed computer network system, and that remotesystem 130, remote expert data center 131 and communication system 130be capable of bi-directional data, voice and video communications withcommunication module 100 via any of the various communications linksdiscussed hereinabove (or combinations thereof). Remote system 130and/or data resource system 112 are preferably located in a centrallocation, equipped with one or more high-speed web-based computernetworks, and manned 24-hours-a-day by remote health care providers 136,physicians 135, operators 136 and/or clinical personnel 136 speciallytrained to provide web-based remote clinical, diagnostic, and/orsoftware services to patient 5, communication module 100 and/or IMD 10.

[0221] Continuing to refer to FIGS. 12A, 12B and 12C, communicationmodule configuration database 126 may include information and dataspecifying both the hardware configuration and the software applicationsor programs installed in various communication modules 100, mobiletelephones or PDAs 110, and/or IMDs 10 located anywhere in the world.For example, communication module configuration database 126 may containinformation such as the amount of RAM contained in a particularcommunication module 100 and/or IMD 10, or the particular set ofcommunication protocols and systems that may be employed to communicatewith, re-program or upgrade the software contained in a particularcommunication module 100, mobile telephone or PDA 110, and/or IMD 10.Depending upon the amount of RAM residing in communication module 100,mobile telephone or PDA 110, and/or IMD 10, for example, it may berequired that a given software application be modified prior toinstallation to ensure compatibility between communication module 100,mobile telephone or PDA 110, and/or IMD 10 and the software applicationthat is to be installed. Manager module 124 then executes such softwaremodifications prior to software installation.

[0222] It is preferred that release software database 128 be a softwaredatabase which includes all current software applications or programsdeveloped and configured for various communication modules 100 and/orIMDs 10. It is also preferred that rule set database 133 be a databasecontaining information and data related to specific rules andregulations regarding various software applications for communicationmodule 100 and/or IMD 10. For example, rule set database 133 may containinformation concerning whether a particular software application may ormay not be released and installed in an IMD 10 implanted within apatient 5 located in a particular country, or whether a softwareapplication may or may not be installed due to a lack of approval by agoverning body (such as an governmental agency or regulatory branch).Rule set database 133 may also contain information concerning whetherthe manufacturer, owner, licensee or licensor of a software applicationhas approved installation of the software application into communicationmodule 100 and/or IMD 10.

[0223] Referring now to FIGS. 12B and 12C, an operator located at, nearor remote from remote computer system 130 may interrogate one or morecommunication modules 100, mobile telephones or PDAs 110, and/or IMDs10, or may pre-program an interrogation schedule for one or morecommunication modules 100, mobile telephones or PDAs 110, and/or IMDs 10to be interrogated, by remote system 130 via communication system 120for any of a variety of reasons. For example, it may be desired toretrieve clinical or diagnostic data or information from many IMDs 10 ofa similar type and transfer such information to remote system 130 and/ordata resource system 112 for storage or later evaluation in a clinicalstudy. Alternatively, it may be desired to retrieve diagnostic orperformance data from IMD 10 and/or communication module 100 on anas-required or basis or according to a pre-determined schedule.

[0224] In a preferred embodiment of the present invention, andregardless of the purpose for which communication module 100 and/or IMD10 is connected with or interrogated by remote system 130, remote system130 and/or data resource system 112 may be configured to automaticallyreview the various hardware configurations and software applicationscontained in communication module 100 and/or IMD 10. Updated softwareapplications may therefore be installed automatically, if available andapproved for installation in a particular communication module 100and/or IMD 10. In some cases, such software installation may be a bytelevel update to software already residing in the communication module100 and/or IMD 10. In other cases, such software installation maycomprise replacing an outdated software application with a newapplication. In one method of the present invention, remote health careprovider 136 is presented with the choice of whether or not to proceedwith the installation of new software applications. Remote health careprovider 136 may also disable or defer installation of new or updatedsoftware if communication module 100 is detected as communicating withIMD 10. Such a safety feature helps prevent interference withcommunications between communication module 100 and IMD 10.

[0225] Accordingly, in some embodiments of the present invention thereare provided methods and processes by which remote system 130, actingthrough communication system 120, mobile telephone or PDA 110 and/orcommunication module 100, may monitor the health of patient 5, theperformance and operation of IMD 10, and further debug, update andprogram IMD 10, most preferably through the use of a web-based globallydistributed smart system. As shown in FIG. 12B, and in accordance withthe teachings set forth hereinabove, invoices may be generated atvarious points in the methods of the present invention illustrated inFIGS. 12B and 12C.

[0226] Some embodiments of the present invention may transmit automatedsoftware updates from an expert data center to globally distributed IMDs10 implanted in patients 5, most preferably through a web-basedcommunication system 120. Remote system 130 comprising a globallyaccessible expert data center may be configured to serve individualambulatory patients having IMDs 10 implanted within them who are locatedanywhere in the world where mobile telephone coverage is provided. Thisfeature of the present invention provides significant benefits topatients. Moreover, the Internet compatible, preferably web-based expertdata center may be implemented to upgrade, update, correct and modifythe operational and functional software of communication module 100,which in turn may upgrade the IMD 10 by downloading thereto the requiredsoftware applications or updates.

[0227] We refer now to FIGS. 13A and 13B, where flow charts for twomethods of the present invention relating to emergency-initiatedcommunication between IMD 10 and/or communication module 100/mobiletelephone or PDA 110 and various components of remote system 130 viacommunicaton system 120 are illustrated. It is contemplated in FIGS. 13Aand 13B that a PDA, PDA-capable mobile telephone or PDA-type device beoptionally employed, either as a replacement for mobile telephone 110,in addition to mobile telephone 110 or as part of mobile telephone 110.

[0228] In FIG. 13A, patient 5, IMD 10 and/or communication module100/mobile telephone or PDA 110 at step 501 determines or desires thatemergency medical attention should be provided or is required. Such adetermination or desire may be based on physiological events whichpatient 5 or others in his company sense, may be based upon thepatient's feeling or desire that his health status or the performancestatus of his IMD 10 ought to be checked immediately, or uponphysiological events sensed in patient 5 by IMD 10.

[0229] At step 503, patient 5, device 10 and/or communication module 100or mobile telephone or PDA 110 initiates upload of data from IMD 10 tocommunication module 100. IMD 10 and communication module 100 thencommunicate with one another and the data are uploaded. Alternatively,step 503 may be skipped if the desired data have already been uploadedby communication module 100 and are now stored in memory/storage medium105.

[0230] Next, at step 507, the data are transferred from communicationmodule to mobile telephone or PDA 110, and thence on to remote system130 via communication system 120. At step 509, remote health careprovider 136, remote computer system 131 and/or 131′, and/or a remoteexpert computer system evaluate, review and analyze the data. In step511, diagnosis of the patient's condition (and/or that of IMD 10,communication module 100, and/or mobile telephone or PDA 110) is made byone or more of remote health care provider 136, remote computer system131 and/or 131′, and/or a remote expert computer system.

[0231] At step 513, any one or more of remote health care provider 136,remote computer system 131 and/or 131′, and/or a remote expert computersystem determines, on the basis of the analysis, whether patient 5,communication module 100, mobile telephone or PDA 110 and/or IMD 10require further attention, correction or intervention. If the analysisreveals that patient 5, communication module 100, mobile telephone orPDA 110 and/or IMD 10 is or are functioning normally within acceptablelimits, patient 5, IMD 10 and/or communication module 100/mobiletelephone or PDA 110 may be so notified via communication system 120,mobile phone 110 such as by, for example, a visual display or audiosignal emitted by communication module 100 (or mobile phone or PDA 110).

[0232] If, on the other hand, the analysis reveals that a problem existsin respect of any one or more of IMD 10, communication module 100,mobile telephone or PDA 110, and/or patient 5, then remote system 130and/or health care provider 136 determines an appropriate remedialresponse to the problem, such as changing the operating parameters ofIMD 10, communication module 100 and/or mobile telephone or PDA 110,delivering a therapy to the patient (e.g., a pacing, cardioverting ordefibrillating therapy, or administration of a drug or other beneficialagent to patient 5), or instructing patient 5 by audio, visual or othermeans to do something such as lie down, go to the hospital, call anambulance, take a medication, or push a button.

[0233] The remedial response or therapy determined in step 517 is nextexecuted at step 519 by remote health care provider 136 or remote system130 and relayed at step 521 via communication system 120 tocommunication module 100 and/or IMD 10 via mobile phone or PDA 110.After the remedial response or therapy has been delivered, at step 525communication module and/or mobile telephone 110 may send a confirmatorymessage to remote system 130 and/or remote care giver 136 indicatingthat the remedial response or therapy has been delivered to patient 5and/or IMD 10. Communication module 100 and/or mobile telephone or PDA110 may also store data concerning the patient-initiated chain of eventsdescribed above so that the data may be later retrieved, analyzed,and/or a future therapy determined at least partially on the basis ofsuch data. Such data may also be stored by remote data system 130 forlater retrieval, analysis and/or future therapy determination.

[0234] It is to be noted that all steps illustrated in FIG. 13A need notbe carried out to fall within the scope of the present invention.Indeed, it is contemplated in the present invention that some stepsillustrated in FIG. 13A may be eliminated or not carried out, that stepsillustrated in FIG. 13A may be carried out in an order different fromthat shown in FIG. 13A, that steps other than those explicitlyillustrated in the Figures may be inserted, and that steps illustratedin different Figures set forth herein (i.e., FIGS. 9A, 9B, 9C, 10A, 10B,11A, 11B, 12 a, 12B, 12C and 13B) be combined in various combinationsand permutations, and nevertheless fall within the scope of certainembodiments of the present invention. The same considerations hold truefor all flow charts and methods illustrated in the drawings hereof anddescribed herein.

[0235] In FIG. 13B, some of the same steps shown in FIG. 13A areexecuted. Invoice generation steps 529 may be automatically generated inconjunction with or in response to one or more of steps 501, 504, 507,513A, 513B, 517, 523 or 527 being carried out. The invoices so generatedmay be electronically transmitted to appropriate locations for furtherprocessing and billing. The amounts of the invoices so generated maydepend, for example, on the number, type and/or frequency of servicesprovided to patient, the type or identification indicia stored incommunication module 100 or IMD 10, and other factors.

[0236] In the methods illustrated in FIGS. 13A and 13B it is furthercontemplated that the patient be alerted by audio or visual means thatno emergency treatment of her condition is required if an erroneous orunnecessary request for emergency treatment is initiated by patient 5,that communication module 100 and/or mobile telephone or PDA 110 alertpatient 5 through audio or visual means that the patient is required totake a particular action such as pressing an appropriate button orcalling an ambulance when an emergency health condition has beendetected, and that communication module 100 and/or mobile telephone orPDA 110 dial 911 when an emergency health condition has been detected.

[0237] In the devices and methods illustrated in the various Figureshereof, it is further contemplated that a prescription table particularto patient 5 be stored in IMD 10, communication module 100, mobiletelephone or PDA 110, and/or remote system 130 that may be quickly andreadily read, activated or deactivated, implemented or updated; that aremote health care provider 136 may prescribe an initial therapy, drugdosage or drug prescription regime or range for patient 5 that may laterbe adjusted, reprogrammed or changed remotely after data acquired in IMDhave been remotely analyzed; that a remote health care provider 136 orremote system 130 may track the history of the programming of IMD 10 andarchive data retrieved from IMD 10; that a remote health care provider136 or remote system 130 may also track the history of the programmingof device IMD, create corresponding patient history files, and sell sameto physicians, insurance companies and/or reimbursement authorities; andthat a patient's condition be monitored and followed remotely such as,by way of example only, checking the minute ventilation status of apatient in an ALS disease clinical where the progression of ALS diseaseis being monitored remotely.

[0238] It is to be noted that the present invention is not limited touse in conjunction with implanted defibrillators or pacemakers, but maybe practiced in conjunction with any suitable implantable medical deviceincluding, but not limited to, an implantable nerve stimulator or musclestimulator such as those disclosed in U.S. Pat. No. 5,199,428 to Obel etal., U.S. Pat. No. 5,207,218 to Carpentier et al. and U.S. Pat. No.5,330,507 to Schwartz, an implantable monitoring device such as thatdisclosed in U.S. Pat. No. 5,331,966 issued to Bennet et al., animplantable brain stimulator, an implantable gastric system stimulator,an implantable vagus nerve stimulator, an implantable lower colonstimulator (e.g., in graciloplasty applications), an implantable drug orbeneficial agent dispenser or pump, an implantable cardiac signal loopor any other type of implantable recorder or monitor, an implantablegene therapy delivery device, an implantable incontinence prevention ormonitoring device, or an implantable insulin pump or monitoring device,and so on. Moreover, a wide variety of communication methods, protocolsand techniques may be employed in various portions of the communicationsystems of the present invention, including, but not limited to,optical, electro-optical, magnetic, infrared, ultrasonic and hard-wiredcommunication means.

[0239] Thus, the present invention is believed to find wide applicationin almost any appropriately adapted implantable medical device. Indeed,the present invention may be practiced in conjunction with any suitablenon-implanted medical device, such as a Holter monitor, an external EKGor ECG monitor, an external cardiac signal loop recorder, an externalblood pressure monitor, an external blood glucose monitor, a temporarycardiac pacing system having an external pulse generator, and the like.

[0240] For example, the present invention includes within its scope asystem comprising an implantable medical device capable ofbi-directional communication with a communication module located outsidethe patient, the communication module in turn being capable ofbi-directional communication with a remote system via a mobiletelephone, the system further comprising at least one implantable ornon-implantable device operably connected to, implanted within orassociated with the patient, the device being capable of bi-directionalcommunication with the communication module. In such a manner, multiplephysiologic signals, events or statuses of the patient may be monitoredor controlled remotely through the communication module and the mobiletelephone.

[0241] Although specific embodiments of the invention are described herein some detail, it is to be understood that those specific embodimentsare presented for the purpose of illustration, and are not to be takenas somehow limiting the scope of the invention defined in the appendedclaims to those specific embodiments. It is also to be understood thatvarious alterations, substitutions, and modifications may be made to theparticular embodiments of the present invention described herein withoutdeparting from the spirit and scope of the appended claims.

[0242] In the claims, means plus function clauses are intended to coverthe structures and devices described herein as performing the recitedfunction and their equivalents. Means plus function clauses in theclaims are not intended to be limited to structural equivalents only,but are also intended to include structures and devices which functionequivalently in the environment of the claimed combination.

[0243] All printed publications, patents and patent applicationsreferenced hereinabove are hereby incorporated by referenced herein,each in its respective entirety.

We claim:
 1. A communication system for at least one of monitoring theperformance of an implantable medical device (IMD) implanted within abody of a patient, monitoring the health of the patient and remotelydelivering a therapy to the patient through the IMD, the IMD beingcapable of bi-directional communication with a communication modulelocated external to the patient's body, the system comprising: (a) theIMD, the IMD comprising a memory having software loaded therein andmeans for permitting the software to be at least one of updated andreprogrammed after the IMD has been implanted within the patient's body,and (b) the communication module, the communication module furthercomprising means for at least one of updating and reprogramming at leastportions of the software loaded in the IMD; (c) a mobile telephoneoperably connected to the communication module and capable of receivingsoftware information therefrom or relaying software information thereto;(e) a remote computer system capable of initiating the downloading ofupdated or new software to the IMD via the communication system and thecommunication module; (f) a communication system capable ofbi-directional communication with the mobile phone and the remotecomputer system.
 2. The system of claim 1, wherein the communicationmodule is incorporated into the mobile telephone.
 3. The system of claim1, wherein the mobile telephone further comprises a Personal DataAssistant (PDA).
 4. The system of claim 1, wherein the communicationmodule is a device separate and apart from the mobile telephone.
 5. Thesystem of claim 1, wherein the IMD and the communication modulecommunicate with one another using radio-frequency telemetry.
 6. Thesystem of claim 1, wherein the communication module further comprises atleast one of a microprocessor, a controller, a CPU, a computer readablememory operably connected to a processor, and at least one RFcommunications circuit for transmitting information to and receivinginformation from the IMD.
 7. The system of claim 1, wherein thecommunication module further comprises a data output port, cable andconnector for connection to a mobile telephone data input port of themobile telephone.
 8. The system of claim 1, wherein the communicationmodule further comprises in a memory thereof computer readable softwarefor initiating and maintaining communications with the mobile telephoneusing standardized handshake protocols.
 9. The system of claim 1,wherein the communication module further comprises at least one of atelemetry signal strength indicator and a telemetry session successindicator.
 10. The system of claim 1, wherein the communication modulefurther comprises at least one of volatile RAM, non-volatile RAM, ROM,EEPROM, a hard or floppy disk, and flash memory for storing at least oneof patient data, IMD data, and software.
 11. The system of claim 1,wherein the communication module further comprises at least one of areal-time clock, a battery, a serial output interface and a paralleloutput interface.
 12. The system of claim 1, wherein the communicationmodule is adapted to receive electrical power from at least one of aportable energy source disposed therewithin or connected thereto, aportable energy source disposed within or connected to the mobiletelephone, and household line ac power.
 13. The system of claim 1,wherein the communication module is plug-and-play compatible with themobile telephone.
 14. The system of claim 1, wherein the communicationmodule, upon receiving instruction from the patient, the remote computersystem or a remote health care provider, further comprises means forinterrogating the IMD to assess the operational performance thereof,upload data therefrom, or assess the health status of the patient. 15.The system of claim 14, the wherein communication module furthercomprises means for storing information obtained from the IMD in acomputer readable medium.
 16. The system of claim 14, wherein thecommunication module further comprises means for relaying informationobtained from the IMD to the remote computer via the mobile telephone.17. The system of claim 1, wherein the communication module, uponreceiving instruction from the remote computer or a remote health careprovider, further comprises means for interrogating the IMD to assessthe operational performance thereof, upload data therefrom, or assessthe health status of the patient.
 18. The system of claim 17, whereinthe communication module further comprises means for storing informationobtained from the IMD in a computer readable medium.
 19. The system ofclaim 17, wherein the communication module further comprises means forrelaying information obtained from the IMD to the remote computer viathe mobile telephone.
 20. The system of claim 1, wherein thecommunication system further comprises at least one of a mobiletelephone network, the Internet, a Local Area Network (LANs), a WideArea Network (WAN), an Integrated Services Digital Network (ISDN), aPublic Switched Telephone Network (PSTNs), a wireless network, anasynchronous transfer mode (ATM) network, and a satellite.
 21. Thesystem of claim 1, wherein the communication module further comprisesmeans for managing and updating software relating to at least one of theoperational and functional parameters of the communication module or theIMD.
 22. The system of claim 1, wherein the communication module furthercomprises means for defecting a fault in the operation or circuitrythereof.
 23. The system of claim 22, wherein the communication modulefurther comprises means for correcting a detected fault in operation orcircuitry the communication module and means for notifying the remotecomputer system or the patient that the fault has been detected orcorrected.
 24. The system of claim 1, wherein the communication modulefurther comprises means for defecting a fault in the operation orcircuitry of the IMD.
 25. The system of claim 24, wherein thecommunication module further comprises means for correcting a detectedfault in the operation or circuitry of the IMD and means for notifyingthe remote computer system or the patient that a fault has been detectedor corrected.
 26. The system of claim 1, further comprising means formining at least one of patient history, performance parameter integrityand software status from the communication module.
 27. The system ofclaim 1, further comprising means for generating automatic invoices inresponse to a patient-initiated, IMD-initiated, remote computersystem-initiated, communication module-initiated, mobile phone-initiatedand a PDA-initiated transmission or reception of information that one oforiginates in or relates to the IMD.
 28. The system of claim 1, whereinthe communication module comprises at least one of means for monitoringthe performance of the IMD, and means for monitoring physiologic signalsor data indicative of the patient's health status.
 29. A communicationsystem for at least one of monitoring the performance of an implantablemedical device (IMD) implanted within a body of a patient, monitoringthe health of the patient and remotely delivering a therapy to thepatient through the IMD, the IMD being capable of bi-directionalcommunication with at least one of a mobile telephone and a PersonalData Assistant (PDA) located external to the patient's body, the systemcomprising: (a) the IMD, the IMD comprising a memory having softwareloaded therein and means for permitting the software to be at least oneof updated and reprogrammed after the IMD has been implanted within thepatient's body; (b) the at least one of the mobile telephone and thePDA, the at least one of the mobile telephone and the PDA furthercomprising means for at least one of updating and reprogramming at leastportions of the software loaded in the IMD, the at least one of themobile telephone and the PDA being capable of receiving information fromor relaying information to the IMD; (c) a remote computer system capableof initiating the downloading of updated or new software to the IMD viathe communication system and the communication module; and (d) acommunication system capable of bi-directional communication with the atleast one of the mobile telephone and the PDA.
 30. The system of claim29, wherein the PDA is incorporated into the mobile telephone.
 31. Thesystem of claim 29, wherein the PDA is operably connected to the mobiletelephone.
 32. The system of claim 29, wherein the IMD and the at leastone of the mobile telephone and the PDA communicate with one anotherusing radio-frequency telemetry.
 33. The system of claim 29, wherein theat least one of the mobile telephone and the PDA further comprises atleast one of a microprocessor, a controller, a CPU, a computer readablememory operably connected to a processor, and at least one RFcommunications circuit for transmitting information to and receivinginformation from the IMD.
 34. The system of claim 29, wherein the atleast one of the mobile telephone and the PDA further comprises a dataoutput port, cable and connector for connection to an external device.35. The system of claim 29, wherein the at least one of the mobiletelephone and the PDA further comprises in a memory thereof computerreadable software for initiating and maintaining communications with theIMD using standardized handshake protocols.
 36. The system of claim 29,wherein the at least one of the mobile telephone and the PDA furthercomprises at least one of a telemetry signal strength indicator and atelemetry session success indicator.
 37. The system of claim 29, whereinthe at least one of the mobile telephone and the PDA further comprisesat least one of volatile RAM, non-volatile RAM, ROM, EEPROM, a hard orfloppy disk, and flash memory for storing at least one of patient data,IMD data, and software.
 38. The system of claim 29, wherein the at leastone of the mobile telephone and the PDA further comprises at least oneof a real-time clock, a battery, a serial output interface and aparallel output interface.
 39. The system of claim 29, wherein the atleast one of the mobile telephone and the PDA is adapted to receiveelectrical power from at least one of a portable energy source disposedtherewithin or connected thereto and household line ac power.
 40. Thesystem of claim 29, wherein the PDA is plug-and-play compatible with themobile telephone.
 41. The system of claim 29, wherein the at least oneof the mobile telephone and the PDA, upon receiving instruction from thepatient, the remote computer system or a remote health care provider,farther comprises means for interrogating the IMD to assess theoperational performance thereof, upload data therefrom, or assess thehealth status of the patient.
 42. The system of claim 41, wherein the atleast one of the mobile telephone and the PDA further comprises meansfor storing information obtained from the IMD in a computer readablemedium.
 43. The system of claim 41, wherein the at least one of themobile telephone and the PDA further comprises means for relayinginformation obtained from the IMD to the remote computer via the mobiletelephone.
 44. The system of claim 29, wherein the at least one of themobile telephone and the PDA, upon receiving instruction from the remotecomputer or a remote health care provider, further comprises means forinterrogating the IMD to assess the operational performance thereof,upload data therefrom, or assess the health status of the patient. 45.The system of claim 44, wherein the at least one of the mobile telephoneand the PDA further comprises means for storing information obtainedfrom the IMD in a computer readable medium.
 46. The system of claim 45,wherein at least one of the mobile telephone and the PDA furthercomprises means for relaying information obtained from the IMD to theremote computer via the mobile telephone.
 47. The system of claim 29,wherein the communication system further comprises at least one of amobile telephone network, the Internet, a Local Area Network (LANs), aWide Area Network (WAN), an Integrated Services Digital Network (ISDN),a Public Switched Telephone Network (PSTNs), a wireless network, anasynchronous transfer mode (ATM) network, and a satellite.
 48. Thesystem of claim 29, wherein the at least one of the mobile telephone andthe PDA further comprises means for managing and updating softwarerelating to at least one of the operational and functional parameters ofthe communication module or the IMD.
 49. The system of claim 29, whereinthe at least one of the mobile telephone and the PDA further comprisesmeans for defecting a fault in the operation or circuitry thereof. 50.The system of claim 49, wherein the at least one of the mobile telephoneand the PDA further comprises means for correcting a detected fault inoperation or circuitry the communication module and means for notifyingthe remote computer system or the patient that the fault has beendetected or corrected.
 51. The system of claim 29, wherein the at leastone of the mobile telephone and the PDA further comprises means fordefecting a fault in the operation or circuitry of the IMD.
 52. Thesystem of claim 51, wherein the at least one of the mobile telephone andthe PDA further comprises means for correcting a detected fault in theoperation or circuitry of the IMD and means for notifying the remotecomputer system or the patient that a fault has been detected orcorrected.
 53. The system of claim 29, further comprising means formining at least one of patient history, performance parameter integrityand software status from the at least one of the mobile telephone andthe PDA.
 54. The system of claim 29, further comprising means forgenerating automatic invoices in response to a patient-initiated,IMD-initiated, remote computer system-initiated, communicationmodule-initiated, mobile phone-initiated and a PDA-initiatedtransmission or reception of information that one of originates in orrelates to the IMD.
 55. The system of claim 29, wherein the at least oneof the mobile telephone and the PDA comprises at least one of means formonitoring the performance of the IMD, and means for monitoringphysiologic signals or data indicative of the patient's health status.56. A software updating communication module for use in conjunction withan implantable medical device (IMD) implanted within a body of apatient, the IMD being capable of bi-directional communication with acommunication module located external to the patient's body, wherein thesystem comprises the IMD, the module, a mobile telephone, a remotecomputer system and a communication system, the IMD comprising a memoryhaving software loaded therein and means for permitting the software tobe at least one of updated and reprogrammed after the IMD has beenimplanted within the patient's body, the mobile telephone being operablyconnected to the communication module and capable of uploading softwaretherefrom or downloading software thereto, the remote computer systembeing capable of initiating the downloading of updated or new softwareto the IMD via the communication system and the communication module,the communication system being capable of bi-directional communicationwith the mobile phone and the remote computer system, the communicationmodule further comprising means for at least one of updating andreprogramming at least portions of the software loaded in the IMD. 57.At least one of a mobile telephone and a Personal Data Assistant (PDA)for facilitating updating and installing new software in an implantablemedical device (IMD) implanted within a body of a patient, the IMD beingcapable of bi-directional communication with the at least one of themobile telephone and the PDA located external to the patient's body, theat least one of the mobile telephone and the PDA forming a portion of asystem comprising the IMD, the at least one of the mobile telephone andthe PDA, a remote computer and a communication system, the IMDcomprising a memory having software loaded therein and means forpermitting the software to be at least one of updated and reprogrammedafter the IMD has been implanted within the patient's body, the at leastone of the mobile telephone and the PDA further comprising means for atleast one of updating and reprogramming at least portions of thesoftware loaded in the IMD, the at least one of the mobile telephone andthe PDA being capable of uploading software from or downloading softwareto the IMD, the remote computer system being capable of initiating thedownloading of updated or new software to the IMD via the communicationsystem and the at least one of the mobile telephone and the PDA, thecommunication system being capable of bi-directional communication withthe at least one of the mobile telephone and the PDA.
 58. A method ofupdating or installing new software in an implantable medical device(IMD) implanted in a patient, the IMD being capable of bi-directionalcommunication with a communication module located external to thepatient's body, the IMD comprising a memory having software loadedtherein and means for permitting the software to be at least one ofupdated and reprogrammed after the IMD has been implanted within thepatient's body, the IMD forming a portion of a system comprising theIMD, a communication module, a mobile telephone capable of beingoperably connected to the communication module and capable of receivinginformation therefrom or relaying information thereto, a remote computersystem, and a communication system capable of bi-directionalcommunication with the mobile phone and the remote computer system, themethod comprising: (a) the patient or the remote computer systemdetermining that at least one of at least portions of the softwareloaded in the memory of the IMD should be updated and or changed, and(b) transmitting new or updated software to the IMD via the mobiletelephone and the communication module.
 59. A method of updating orinstalling new software in an implantable medical device (IMD) implantedin a patient, at least one of a mobile telephone and a Personal DataAssistant (PDA) located external to the patient's body, the IMDcomprising a memory having software loaded therein and means forpermitting the software to be at least one of updated and reprogrammedafter the IMD has been implanted within the patient's body, the IMDforming a portion of a system comprising the IMD, the at least one ofthe mobile telephone and the PDA, a communication system and a remotecomputer system, the at least one of the mobile telephone and the PDAbeing capable of receiving information from or relaying information tothe IMD, a remote computer system, and a communication system capable ofbi-directional communication with the at least one of the mobiletelephone and the PDA, the method comprising: (a) the patient or theremote computer system determining that at least one of at leastportions of the software loaded in the memory of the IMD should beupdated and or changed, and (b) transmitting new or updated software tothe IMD via the at least one of the mobile telephone and the PDA.